2011501343 Health Library | Health and Wellness | Wellmont Health System
  • Hydrocodone

    (hye droe koe' done)

    WHY is this medicine prescribed?

    Hydrocodone is available only in combination with other ingredients, and different combination products are prescribed for different uses. Some hydrocodone products are used to relieve moderate to severe pain. Other hydrocodone products are used to relieve cough. Hydrocodone is in a class of medications called opiate (narcotic) analgesics and in a class of medications called antitussives. Hydrocodone relieves pain by changing the way the brain and nervous system respond to pain. Hydrocodone relieves cough by decreasing activity in the part of the brain that causes coughing.
    Hydrocodone must be used with caution in children. Extended-release products containing hydrocodone should not be given to children younger than 6 years of age and should be used with caution in children 6-12 years of age. Talk to your doctor about the risks of giving hydrocodone to your child.
    You will take hydrocodone in combination with at least one other medication, but this monograph only provides information about hydrocodone. Be sure to read information about the other ingredients in the hydrocodone product you are taking. Ask your doctor or pharmacist if you have any questions.

    HOW should this medicine be used?

    Hydrocodone comes as a tablet, a capsule, a syrup, a solution (clear liquid), an extended-release (long-acting) capsule, and an extended-release (long-acting) suspension (liquid) to take by mouth. The tablet, capsule, syrup, and solution are usually taken every 4-6 hours as needed. The extended-release capsule and the extended-release suspension are usually taken every 12 hours as needed. If you are taking hydrocodone on a regular schedule, take it at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
    Swallow the extended-release capsules whole; do not split, chew, or crush them.
    Shake the extended-release suspension well before each use to mix the medication evenly. Do not mix the extended-release suspension with other medications or with other liquids such as water.
    If you will be using hydrocodone solution, syrup, or extended-release suspension, do not use a household teaspoon to measure your dose. Household teaspoons are not accurate measuring devices, and you may receive too much medication or not enough medication if you measure your dose with a household teaspoon. Instead, use a properly marked measuring device such as a dropper, medicine spoon, or oral syringe. Ask your doctor or pharmacist if you need help getting or using a measuring device.
    Call your doctor if your symptoms are not controlled by the hydrocodone product you are taking. Do not increase your dose of medication on your own. You may receive a dangerous overdose if you take more medication or take your medication more often than prescribed by your doctor.
    Hydrocodone may be habit-forming. Take hydrocodone exactly as directed. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor. Call your doctor if you develop a strong desire to take more medication than prescribed.
    If you have taken hydrocodone for several weeks or longer, do not stop taking the medication without talking to your doctor. If you suddenly stop taking hydrocodone, you may experience withdrawal symptoms. Your doctor will probably decrease your dose gradually.
    Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient, available for certain hydrocodone combination products.

    Are there OTHER USES for this medicine?

    This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking hydrocodone,
    • tell your doctor and pharmacist if you are allergic to hydrocodone, the other medication in the hydrocodone combination product you are taking, other opiate (narcotic) medications such as morphine or codeine, or any other medications.
    • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants; antihistamines; antipsychotics (medications for mental illness); ipratropium (Atrovent); medications for irritable bowel disease, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems; monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate); sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
    • tell your doctor if you have recently had surgery and if you have or have ever had lung disease; breathing problems; croup (a barking cough that most often occurs at night); a head injury; any condition that causes increased pressure in your brain; prostatic hypertrophy (enlargement of a male reproductive gland); urethral stricture (narrowing of the tube that removes urine from the body); Addison's disease (condition in which the body does not make enough of certain natural substances); glaucoma; or thyroid, intestinal, liver, or kidney disease.
    • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking hydrocodone, call your doctor.
    • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking hydrocodone.
    • you should know that hydrocodone may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
    • ask your doctor about the safe use of alcoholic beverages while you are taking hydrocodone. Alcohol can make the side effects from hydrocodone worse.

    What SPECIAL DIETARY instructions should I follow?

    Unless your doctor tells you otherwise, continue your normal diet.

    What should I do IF I FORGET to take a dose?

    This medication is usually taken as needed. If your doctor has told you to take hydrocodone regularly, take the missed dose as soon as you remember it. Then wait at least 4 hours before taking your next dose of the tablets, syrup, capsule, or solution, or at least 12 hours before taking your next dose of the extended-release capsules or extended-release solution. If it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

    What SIDE EFFECTS can this medicine cause?

    Hydrocodone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
    • nausea
    • vomiting
    • constipation
    • drowsiness
    • dizziness
    • lightheadedness
    • fuzzy thinking
    • anxiety
    • abnormally happy or abnormally sad mood
    • dry throat
    • difficulty urinating
    • rash
    • itching
    • narrowing of the pupils (black circles in the center of the eyes)
    Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
    • slowed or irregular breathing
    • chest tightness
    Hydrocodone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
    Store hydrocodone in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many tablets or capsules or how much liquid is left so you will know if any medication is missing.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
    Symptoms of overdose may include:
    • narrowed or widened pupils
    • slow, shallow, or stopped breathing
    • slowed or stopped heartbeat
    • cold, clammy, or blue skin
    • excessive sleepiness
    • loss of consciousness
    • seizures
    • death

    What OTHER INFORMATION should I know?

    Keep all appointments with your doctor.
    Do not let anyone else take your medication. Hydrocodone is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.
    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    Brand Names

    • Allay® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Alor® (as a combination product containing Aspirin, Hydrocodone)[¶]
    • Anexsia® (as a combination product containing Acetaminophen, Hydrocodone)
    • Anolor DH5® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Atuss HD® (as a combination product containing Chlorpheniramine, Hydrocodone, Phenylephrine)[¶]
    • Azdone® (as a combination product containing Aspirin, Hydrocodone)[¶]
    • Baltussin HC® (as a combination product containing Chlorpheniramine, Hydrocodone, Phenylephrine)[¶]
    • Bancap HC® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Ceta Plus® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Codiclear DH® (as a combination product containing Guaifenesin, Hydrocodone)[¶]
    • Co-Gesic® (as a combination product containing Acetaminophen, Hydrocodone)
    • Damason-P® (as a combination product containing Aspirin, Hydrocodone)[¶]
    • Dolacet® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Dolagesic® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Dolorex Forte® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Donatussin MAX® (as a combination product containing Carbinoxamine, Hydrocodone, Phenylephrine)[¶]
    • DuoCet® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Endacof XP® (as a combination product containing Guaifenesin, Hydrocodone)[¶]
    • EndaCof-Plus® (as a combination product containing Dexchlorpheniramine, Hydrocodone, Phenylephrine)[¶]
    • Entuss® (as a combination product containing Guaifenesin, Hydrocodone)[¶]
    • Histinex HC® (as a combination product containing Chlorpheniramine, Hydrocodone, Phenylephrine)[¶]
    • Hycet® (as a combination product containing Acetaminophen, Hydrocodone)
    • Hycodan® (as a combination product containing Homatropine, Hydrocodone)
    • Hycomed® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Hycomine Compound® (as a combination product containing Acetaminophen, Caffeine, Chlorpheniramine, Hydrocodone, Phenylephrine)[¶]
    • Hycotuss® (as a combination product containing Guaifenesin, Hydrocodone)[¶]
    • Hydrocet® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Hydrogesic® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Hydromet® (as a combination product containing Homatropine, Hydrocodone)
    • Hy-Phen® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Ibudone® (as a combination product containing Hydrocodone, Ibuprofen)
    • Kwelcof® (as a combination product containing Guaifenesin, Hydrocodone)[¶]
    • Liquicet® (as a combination product containing Acetaminophen, Hydrocodone)
    • Lorcet® (as a combination product containing Acetaminophen, Hydrocodone)
    • Lorcet Plus® (as a combination product containing Acetaminophen, Hydrocodone)
    • Lortab® (as a combination product containing Acetaminophen, Hydrocodone)
    • Lortuss HC® (as a combination product containing Hydrocodone, Phenylephrine)[¶]
    • Margesic-H® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Maxidone® (as a combination product containing Acetaminophen, Hydrocodone)
    • Norco® (as a combination product containing Acetaminophen, Hydrocodone)
    • Oncet® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Panacet® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Panasal® (as a combination product containing Aspirin, Hydrocodone)[¶]
    • Panlor® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Polygesic® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Procet® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Reprexain® (as a combination product containing Hydrocodone, Ibuprofen)
    • Rezira® (as a combination product containing Hydrocodone, Pseudoephedrine)
    • Stagesic® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • T-Gesic® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • TussiCaps® (as a combination product containing Chlorpheniramine, Hydrocodone)
    • Tussionex® (as a combination product containing Chlorpheniramine, Hydrocodone)
    • Ugesic® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Vanacet® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Vanex-HD® (as a combination product containing Chlorpheniramine, Hydrocodone, Phenylephrine)[¶]
    • Vendone® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Vicodin® (as a combination product containing Acetaminophen, Hydrocodone)
    • Vicodin ES® (as a combination product containing Acetaminophen, Hydrocodone)
    • Vicodin HP® (as a combination product containing Acetaminophen, Hydrocodone)
    • Vicoprofen® (as a combination product containing Hydrocodone, Ibuprofen)
    • Vidone® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Xodol® (as a combination product containing Acetaminophen, Hydrocodone)
    • Zamicet® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Zolvit® (as a combination product containing Acetaminophen, Hydrocodone)
    • Zutripro® (as a combination product containing Chlorpheniramine, Hydrocodone, Pseudoephedrine)
    • Zydone® (as a combination product containing Acetaminophen, Hydrocodone)
    • Also available generically

    Other Names

    • dihydrocodeinone
    These branded products are no longer on the market and only generic alternatives are available.

    Acetaminophen and Codeine

    (a set a mee' noe fen) (koe' deen)

    WHY is this medicine prescribed?

    This combination of drugs is used to relieve mild to moderate pain.
    This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

    HOW should this medicine be used?

    The combination of acetaminophen and codeine comes as a tablet, capsule, and liquid to take by mouth. It usually is taken every 6 hours as needed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take acetaminophen and codeine exactly as directed.
    Codeine can be habit-forming. Do not take a larger dose, take it more often, or for a longer period than your doctor tells you to.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking acetaminophen and codeine,
    • tell your doctor and pharmacist if you are allergic to acetaminophen, codeine, sulfite or any other drugs.
    • tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially acetaminophen (Tylenol); antidepressants; medications for cough, cold, or allergies; other pain relievers; sedatives, sleeping pills, tranquilizers; and vitamins.
    • tell your doctor if you have or have ever had liver or kidney disease, a history of alcoholism, lung or thyroid disease, prostatic hypertrophy, or urinary retention.
    • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking acetaminophen and codeine, call your doctor.
    • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking acetaminophen and codeine.
    • you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
    • remember that alcohol can add to the drowsiness caused by this drug.

    What should I do IF I FORGET to take a dose?

    This medication usually is taken as needed. If your doctor has told you to take acetaminophen and codeine regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

    What SIDE EFFECTS can this medicine cause?

    Acetaminophen and codeine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
    • dizziness
    • lightheadedness
    • drowsiness
    • upset stomach
    • vomiting
    • constipation
    • stomach pain
    • rash
    • difficulty urinating
    If you experience either of the following symptoms, call your doctor immediately:
    • difficulty breathing
    • mood changes
    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

    What OTHER INFORMATION should I know?

    Keep all appointments with your doctor.
    Too much acetaminophen may cause liver damage; do not take more than 4000 mg of acetaminophen per day.
    Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    Brand Names

    • Capital® & Codeine (as a combination product containing Acetaminophen, Codeine)
    • Cocet® (as a combination product containing Acetaminophen, Codeine)
    • Codrix® (as a combination product containing Acetaminophen, Codeine)
    • Colrex® (as a combination product containing Acetaminophen, Chlorpheniramine, Codeine, Phenylephrine)
    • Combiflex® ES (as a combination product containing Acetaminophen, Codeine, Magnesium Salicylate, Phenyltoloxamine)
    • Cotabflu® (as a combination product containing Acetaminophen, Chlorpheniramine, Codeine)
    • Fioricet® with Codeine (as a combination product containing Acetaminophen, Butalbital, Caffeine, Codeine)
    • Margesic® #3 (as a combination product containing Acetaminophen, Codeine)
    • Maxiflu® (as a combination product containing Acetaminophen, Codeine, Guaifenesin, Pseudoephedrine)
    • Phenaphen® with Codeine (#3, #4) (as a combination product containing Acetaminophen, Codeine)
    • Phenco-Care® (as a combination product containing Acetaminophen, Codeine)
    • Phenflu® (as a combination product containing Acetaminophen, Codeine, Guaifenesin, Phenylephrine)
    • Phrenilin® with Caffeine, Codeine (as a combination product containing Acetaminophen, Butalbital, Caffeine, Codeine)
    • Pyregesic® (as a combination product containing Acetaminophen, Codeine)
    • Tylagesic® (as a combination product containing Acetaminophen, Codeine)
    • Tylenol® with Codeine (#2, #3, #4) (as a combination product containing Acetaminophen, Codeine)
    • Vopac® (as a combination product containing Acetaminophen, Codeine)

    Other Names

    • APAP and Codeine (as a combination product containing Acetaminophen and Codeine)

    Guaifenesin

    (gwye fen' e sin)

    IMPORTANT WARNING:

    FDA Intends to Remove Some Unapproved Cough, Cold, and Allergy Drugs from the Market

    This safety alert does not apply to this medication, but only to some products which contain this medication. In addition, it is important that you know that there is not a problem with most of the products described in this medication monograph. And some drug companies may decide to seek full approval from the FDA so that they can continue marketing their products.
    On March 2, 2011, the Food and Drug Administration (FDA) issued a safety alert about certain unapproved prescription cough, cold, and allergy products containing this drug in combination with other drugs. These products are not currently approved by the FDA for safety, effectiveness, and quality. FDA asked drug companies to stop shipping most of these products for sale in the US within the next 6 months. Although some of these products have been marketed for many years, laws about what a company must prove to FDA for drug product approval have gotten tougher and increased enforcement of these laws is now taking place. The FDA took this action due to concerns about certain potential risks associated with use of these medications. These risks may include:
    • the possibility of improper use in infants and young children
    • potentially risky combinations of ingredients
    • patients receiving too much or too little of the medication because of problems with the way some ''timed-release'' products are made
    If you are concerned that the prescription cough, cold, and allergy medication you are taking is not approved by the FDA, you should talk to your doctor or pharmacist. If the medication you are taking is not approved, your doctor can prescribe another prescription medication or your doctor or pharmacist can suggest an over-the-counter (OTC) cough, cold, and allergy product for your condition. There are many safe and effective alternative approved products that can be taken instead. Your doctor probably prescribed the medicine without knowing that FDA had not approved it. This is because it has been so difficult for doctors and pharmacists to find out that these products are unapproved. For additional information:

    WHY is this medicine prescribed?

    Guaifenesin is used to relieve chest congestion . Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

    HOW should this medicine be used?

    Guaifenesin comes as a tablet, a capsule, an extended-release (long-acting) tablet, dissolving granules, and a syrup (liquid) to take by mouth. The tablets, capsules, dissolving granules, and syrup are usually taken with or without food every 4 hours as needed. The extended-release tablet is usually taken with or without food every 12 hours. Follow the directions on the package or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take guaifenesin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
    Guaifenesin comes alone and in combination with antihistamines, cough suppressants, and decongestants. Ask your doctor or pharmacist for advice on which product is best for your symptoms. Check nonprescription cough and cold product labels carefully before using two or more products at the same time. These products may contain the same active ingredient(s) and taking them together could cause you to receive an overdose. This is especially important if you will be giving cough and cold medications to a child.
    Nonprescription cough and cold combination products, including products that contain guaifenesin, can cause serious side effects or death in young children. Do not give these products to children younger than 4 years of age. If you give these products to children 4 to 11 years of age, use caution and follow the package directions carefully.
    If you are giving guaifenesin or a combination product that contains guaifenesin to a child, read the package label carefully to be sure that it is the right product for a child of that age. Do not give guaifenesin products that are made for adults to children.
    Before you give a guaifenesin product to a child, check the package label to find out how much medication the child should receive. Give the dose that matches the child's age on the chart. Ask the child's doctor if you don't know how much medication to give the child.
    If you are taking the liquid, do not use a household spoon to measure your dose. Use the measuring spoon or cup that came with the medication or use a spoon made especially for measuring medication.
    Swallow the extended-release tablets whole with a full glass of water. Do not break, crush, or chew them.
    If you are taking the dissolving granules, empty the entire contents of the packet onto your tongue and swallow.
    If your symptoms do not improve within 7 days or if you also have a high fever, a rash, or a headache that does not go away, call your doctor.

    Are there OTHER USES for this medicine?

    This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking guaifenesin,
    • tell your doctor and pharmacist if you are allergic to guaifenesin, any other medications, or any of the ingredients in the guaifenesin product you plan to take. Check the package label for a list of the ingredients.
    • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
    • tell your doctor if you smoke and if you have or have ever had a cough that occurs with a large amount of phlegm (mucus) or if you have or have ever had a breathing problem such as asthma, emphysema, or chronic bronchitis. If you will be taking the dissolving granules, tell your doctor if you are on a low magnesium diet or if you have kidney disease.
    • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking guaifenesin, call your doctor.
    • if you have phenylketonuria (PKU, a inherited condition in which a special diet must be followed to prevent mental retardation), you should know that the dissolving granules may be sweetened with aspartame, a source of phenylalanine.

    What SPECIAL DIETARY instructions should I follow?

    Drink plenty of fluids while you are taking this medication.
    Unless your doctor tells you otherwise, continue your normal diet.

    What should I do IF I FORGET to take a dose?

    Guaifenesin is usually taken as needed. If your doctor has told you to take guaifenesin regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

    What SIDE EFFECTS can this medicine cause?

    Guaifenesin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
    • headache
    • nausea
    • vomiting
    Guaifenesin may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

    What OTHER INFORMATION should I know?

    Ask your pharmacist any questions you have about guaifenesin.
    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    Brand Names

    • Bidex®
    • Diabetic Tussin®
    • Ganidin NR®[§]
    • Glytuss®[¶]
    • Guaiatussin®[¶]
    • Guaifen NR®[¶]
    • Guiacough®[¶]
    • Guiatuss®
    • Halotussin®[¶]
    • Humibid E®[§]
    • Hytuss®[¶]
    • Iophen NR®
    • Lotussin®[¶]
    • Mallotuss®[¶]
    • Mastussin®[¶]
    • Miltuss EX®[¶]
    • Mucinex®
    • Mytussin®[¶]
    • Organ-I NR®[§]
    • Organidin NR®[§]
    • Phanasin®[¶]
    • Q-Tussin®
    • Ri-Tussin®[¶]
    • Robitussin®
    • Scot-Tussin®
    • Siltussin SA®
    • Tussin®
    • AccuHist DM® (as a combination product containing Brompheniramine, Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Aldex GS® (as a combination product containing Guaifenesin, Pseudoephedrine)
    • Aldex GS DM® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)
    • Alka-Seltzer Plus Mucus and Congestion® (as a combination product containing Dextromethorphan, Guaifenesin)
    • Allfen DM® (as a combination product containing Dextromethorphan, Guaifenesin)[§]
    • Ambifed® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Ambifed DM® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Aquatab C® (as a combination product containing Carbetapentane, Dextromethorphan, Guaifenesin, Phenylephrine)[§]
    • Aquatab DM® (as a combination product containing Dextromethorphan, Guaifenesin)[§]
    • Betavent® (as a combination product containing Carbetapentane, Guaifenesin)[¶]
    • Biotuss® (as a combination product containing Dextromethorphan, Guaifenesin, Phenylephrine)[§]
    • Bitex® (as a combination product containing Codeine, Guaifenesin)[¶]
    • BP 8® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Bromhist DM® (as a combination product containing Brompheniramine, Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Bromhist PDX® (as a combination product containing Brompheniramine, Dextromethorphan, Guaifenesin, Phenylephrine)[§]
    • Broncholate® (as a combination product containing Ephedrine, Guaifenesin)[¶]
    • Broncopectol® (as a combination product containing Chlorpheniramine, Dextromethorphan, Guaifenesin, Phenylephrine)[§]
    • Brondil® (as a combination product containing Dyphylline, Guaifenesin)[¶]
    • Bronkaid® (as a combination product containing Ephedrine, Guaifenesin)
    • Bronkotuss® (as a combination product containing Chlorpheniramine, Ephedrine, Guaifenesin)[¶]
    • Brontex® (as a combination product containing Codeine, Guaifenesin)[¶]
    • Brontuss® (as a combination product containing Dextromethorphan, Guaifenesin)[§]
    • Brontuss DX® (as a combination product containing Dextromethorphan, Guaifenesin, Phenylephrine)
    • Brontuss SF® (as a combination product containing Dextromethorphan, Guaifenesin, Phenylephrine)
    • Certuss® (as a combination product containing Chlophedianol, Guaifenesin)
    • Certuss Multilayer® (as a combination product containing Carbetapentane, Guaifenesin)[§]
    • Certuss-D® (as a combination product containing Chlophedianol, Guaifenesin, Pseudoephedrine)
    • Cheracol D® (as a combination product containing Dextromethorphan, Guaifenesin)[¶]
    • Cheracol with Codeine® (as a combination product containing Codeine, Guaifenesin)[¶]
    • Cheratussin® (as a combination product containing Codeine, Guaifenesin)[¶]
    • Children's Mucinex Chest Congestion® (as a combination product containing Guaifenesin)
    • Children's Mucinex Cough® (as a combination product containing Dextromethorphan, Guaifenesin)
    • Children's Mucinex Multi-Symptom Cold® (as a combination product containing Dextromethorphan, Guaifenesin, Phenylephrine)
    • Chlordex GP® (as a combination product containing Chlorpheniramine, Dextromethorphan, Guaifenesin, Phenylephrine)[§]
    • Codafen® (as a combination product containing Codeine, Guaifenesin)[¶]
    • Codiclear DH® (as a combination product containing Guaifenesin, Hydrocodone)[¶]
    • Coldmist DM® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Coldmist LA® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Comtrex Deep Chest Cold Non Drowsy® (as a combination product containing Acetaminophen, Guaifenesin)[¶]
    • Coricidin HBP Chest Congestion and Cough® (as a combination product containing Dextromethorphan, Guaifenesin)
    • Coricidin HBP Day and Night Multi-Symptom Cold® (as a combination product containing Acetaminophen, Chlorpheniramine, Dextromethorphan, Guaifenesin)
    • Decon E® (as a combination product containing Guaifenesin, Phenylephrine)[§]
    • Decon G® (as a combination product containing Brompheniramine, Guaifenesin, Phenylephrine)[§]
    • Deconex® (as a combination product containing Guaifenesin, Phenylephrine)[¶]
    • Defen LA® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Despec® (as a combination product containing Guaifenesin, Phenylephrine)
    • Despec NR® (as a combination product containing Dextromethorphan, Guaifenesin, Phenylephrine)
    • Diabetic Tussin DM® (as a combination product containing Dextromethorphan, Guaifenesin)
    • Difil-G® (as a combination product containing Dyphylline, Guaifenesin)
    • Dilex-G® (as a combination product containing Dyphylline, Guaifenesin)[§]
    • Donatuss DC® (as a combination product containing Dihydrocodeine, Guaifenesin, Phenylephrine)[§]
    • Donatussin® (as a combination product containing Guaifenesin, Phenylephrine)
    • Drituss DM® (as a combination product containing Dextromethorphan, Guaifenesin)[§]
    • Duratuss DM® (as a combination product containing Dextromethorphan, Guaifenesin)[¶]
    • Dyfilin GG® (as a combination product containing Dyphylline, Guaifenesin)[¶]
    • Dyflex-G® (as a combination product containing Dyphylline, Guaifenesin)[¶]
    • Dynatuss EX® (as a combination product containing Dextromethorphan, Guaifenesin, Phenylephrine)[§]
    • Dyphylline GG® (as a combination product containing Dyphylline, Guaifenesin)[§]
    • Dyphysin® (as a combination product containing Dyphylline, Guaifenesin)[¶]
    • Endacof XP® (as a combination product containing Guaifenesin, Hydrocodone)[¶]
    • Endacon DM® (as a combination product containing Dextromethorphan, Guaifenesin, Phenylephrine)[§]
    • Entex LA® (as a combination product containing Guaifenesin, Phenylephrine)[§]
    • Entex LQ® (as a combination product containing Guaifenesin, Phenylephrine)
    • Entex PSE® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Entuss® (as a combination product containing Guaifenesin, Hydrocodone)[¶]
    • Exall D® (as a combination product containing Carbetapentane, Guaifenesin, Pseudoephedrine)[§]
    • ExeClear-C® (as a combination product containing Codeine, Guaifenesin)[§]
    • Execof® (as a combination product containing Dextromethorphan, Guaifenesin, Phenylephrine)[§]
    • ExeFen DMX® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)
    • ExeFen IR® (as a combination product containing Guaifenesin, Pseudoephedrine)
    • Expectuss® (as a combination product containing Carbetapentane, Guaifenesin)[§]
    • Fenesin DM® (as a combination product containing Dextromethorphan, Guaifenesin)[§]
    • Ganituss DM NR® (as a combination product containing Dextromethorphan, Guaifenesin)[§]
    • Genetuss 2® (as a combination product containing Dextromethorphan, Guaifenesin, Phenylephrine)[§]
    • Gentex LQ® (as a combination product containing Carbetapentane, Guaifenesin, Phenylephrine)[§]
    • Giltuss® (as a combination product containing Dextromethorphan, Guaifenesin, Phenylephrine)[§]
    • Glycotuss-DM® (as a combination product containing Dextromethorphan, Guaifenesin)[¶]
    • Guaidex TR® (as a combination product containing Chlorpheniramine, Dextromethorphan, Guaifenesin, Methscopolamine, Pseudoephedrine)[§]
    • Guaifen DM® (as a combination product containing Dextromethorphan, Guaifenesin)[¶]
    • Guiadrine DX® (as a combination product containing Dextromethorphan, Guaifenesin)[§]
    • Guiatex PE® (as a combination product containing Guaifenesin, Phenylephrine)[§]
    • Guiatuss DM® (as a combination product containing Dextromethorphan, Guaifenesin)
    • Guiatussin DM® (as a combination product containing Dextromethorphan, Guaifenesin)[¶]
    • Halotussin DM® (as a combination product containing Dextromethorphan, Guaifenesin)[¶]
    • Histacol DM® (as a combination product containing Brompheniramine, Guaifenesin, Dexchlorpheniramine, Pseudoephedrine)[§]
    • HT-Tuss DM® (as a combination product containing Dextromethorphan, Guaifenesin)[§]
    • Humibid CS® (as a combination product containing Dextromethorphan, Guaifenesin)[§]
    • Humibid DM® (as a combination product containing Dextromethorphan, Guaifenesin)[§]
    • Hycotuss® (as a combination product containing Guaifenesin, Hydrocodone)[¶]
    • Iophen C-NR® (as a combination product containing Codeine, Guaifenesin)
    • Iophen DM-NR® (as a combination product containing Dextromethorphan, Guaifenesin)
    • J-Max® (as a combination product containing Guaifenesin, Phenylephrine)
    • Kwelcof® (as a combination product containing Guaifenesin, Hydrocodone)[¶]
    • Lartus® (as a combination product containing Dextromethorphan, Guaifenesin, Phelyephrine)[§]
    • Levall® (as a combination product containing Carbetapentane, Guaifenesin, Phenylephrine)[§]
    • Liquibid D-R® (as a combination product containing Guaifenesin, Phenylephrine)
    • Liquibid PD-R® (as a combination product containing Guaifenesin, Phenylephrine)
    • Lortuss EX® (as a combination product containing Codeine, Guaifenesin, Pseudoephedrine)
    • Lotussin DM® (as a combination product containing Dextromethorphan, Guaifenesin)[¶]
    • Lufyllin-GG® (as a combination product containing Dyphylline, Guaifenesin)[§]
    • Lusonex® (as a combination product containing Guaifenesin, Phenylephrine)[§]
    • Maxiphen® (as a combination product containing Guaifenesin, Phenylephrine)[§]
    • Maxi-Tuss DM® (as a combination product containing Dextromethorphan, Guaifenesin)[§]
    • Medent DM® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Medent LD® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Montephen® (as a combination product containing Guaifenesin, Phenylephrine)[§]
    • Mucinex Cough for Kids® (as a combination product containing Dextromethorphan, Guaifenesin)
    • Mucinex D® (as a combination product containing Guaifenesin, Pseudoephedrine)
    • Mucinex DM® (as a combination product containing Dextromethorphan, Guaifenesin)
    • Muco Fen DM® (as a combination product containing Dextromethorphan, Guaifenesin)[§]
    • Mudrane GG® (as a combination product containing Aminophylline, Ephedrine, Guaifenesin, Phenobarbital)[¶]
    • Mytussin AC® (as a combination product containing Codeine, Guaifenesin)[¶]
    • Mytussin DM® (as a combination product containing Dextromethorphan, Guaifenesin)[¶]
    • Naldecon DX® (as a combination product containing Dextromethorphan, Guaifenesin)[¶]
    • Nalex® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Nariz® (as a combination product containing Guaifenesin, Phenylephrine)[¶]
    • Nasatab LA® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Nortuss EX® (as a combination product containing Dextromethorphan, Guaifenesin)[§]
    • Numonyl DX® (as a combination product containing Dextromethorphan, Guaifenesin, Phenylephrine)[¶]
    • Oratuss® (as a combination product containing Carbetapentane, Guaifenesin, Phenylephrine)[§]
    • Panfil® (as a combination product containing Dyphylline, Guaifenesin)[¶]
    • PediaCare Children's Cough and Congestion® (as a combination product containing Dextromethorphan, Guaifenesin)
    • Pediahist DM® (as a combination product containing Brompheniramine, Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Phencarb GG® (as a combination product containing Carbetapentane, Guaifenesin, Phenylephrine)[§]
    • Phenydex® (as a combination product containing Dextromethorphan, Guaifenesin, Pyrilamine)[§]
    • Poly Hist CB® (as a combination product containing Carbetapentane, Guaifenesin)[§]
    • Poly-Tussin EX® (as a combination product containing Dihydrocodeine, Guaifenesin, Phenylephrine)[§]
    • Polyvent® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Primatene® (as a combination product containing Ephedrine, Guaifenesin)
    • Prolex DM® (as a combination product containing Dextromethorphan, Guaifenesin)[§]
    • Prolex PD® (as a combination product containing Guaifenesin, Phenylephrine)[§]
    • Pulmari GP® (as a combination product containing Carbetapentane, Guaifenesin)[§]
    • Q-BID DM® (as a combination product containing Dextromethorphan, Guaifenesin)[§]
    • Q-Tussin DM® (as a combination product containing Dextromethorphan, Guaifenesin)
    • Quartuss® (as a combination product containing Chlorpheniramine, Dextromethorphan, Guaifenesin, Phenylephrine)[§]
    • Quibron® (as a combination product containing Guaifenesin, Theophylline)[¶]
    • Quintex® (as a combination product containing Guaifenesin, Phenylephrine)[§]
    • Respa 1st® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Respa DM® (as a combination product containing Dextromethorphan, Guaifenesin)[§]
    • Respa PE® (as a combination product containing Guaifenesin, Phenylephrine)[§]
    • Respaire® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Respi Tann G® (as a combination product containing Carbetapentane, Guaifenesin)[§]
    • Robafen AC® (as a combination product containing Guaifenesin, Codeine)
    • Robitussin Cough and Chest DM® (as a combination product containing Dextromethorphan, Guaifenesin)
    • Robitussin Cough and Cold CF® (as a combination product containing Dextromethorphan, Guaifenesin, Phenylephrine)
    • Ru-Tuss DM® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Scot-Tussin DM® (as a combination product containing Chlorpheniramine, Dextromethorphan)
    • Scot-Tussin Senior® (as a combination product containing Guaifenesin, Dextromethorphan)
    • Siltussin DM® (as a combination product containing Dextromethorphan, Guaifenesin)
    • Simuc DM® (as a combination product containing Dextromethorphan, Guaifenesin)[§]
    • Sine-Off Cough/Cold® (as a combination product containing Acetaminophen, Dextromethorphan, Guaifenesin, Phenylephrine)
    • Sine-Off Severe Cold® (as a combination product containing Acetaminophen, Guaifenesin, Phenylephrine)
    • Sinutuss DM® (as a combination product containing Dextromethorphan, Guaifenesin, Phenylephrine)[§]
    • Sinuvent PE® (as a combination product containing Guaifenesin, Phenylephrine)[§]
    • Sitrex® (as a combination product containing Guaifenesin, Phenylephrine)[§]
    • Sudafed PE Cold/Cough® (as a combination product containing Acetaminophen, Dextromethorphan, Guaifenesin, Phenylephrine)
    • Sudafed PE Day/Night Cold® (as a combination product containing Acetaminophen, Dextromethorphan, Diphenhydramine, Guaifenesin, Phenylephrine)
    • Sudafed PE Non-Drying Sinus® (as a combination product containing Guaifenesin, Phenylephrine)
    • Sudafed PE Triple Action® (as a combination product containing Acetaminophen, Guaifenesin, Phenylephrine)
    • Sudafed Triple Action® (as a combination product containing Acetaminophen, Guaifenesin, Pseudoephedrine)
    • Sudatex DM® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Tenar DM® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Tenar PSE® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Theraflu Flu and Chest Congestion® (as a combination product containing Acetaminophen, Guaifenesin)
    • Theraflu Max-D Severe Cold and Flu® (as a combination product containing Acetaminophen, Dextromethorphan, Guaifenesin, Pseudoephedrine)
    • Touro CC® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Touro DM® (as a combination product containing Dextromethorphan, Guaifenesin)[§]
    • Touro LA® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Triaminic Chest and Nasal Congestion® (as a combination product containing Guaifenesin, Phenylephrine)
    • Trikof D® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Trispec DMX® (as a combination product containing Dextromethorphan, Guaifenesin)[§]
    • Trispec PSE® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Trituss® (as a combination product containing Dextromethorphan, Guaifenesin, Phenylephrine)[§]
    • Tusnel® (as a combination product containing Brompheniramine, Dextromethorphan, Guaifenesin)[§]
    • Tussafed EX® (as a combination product containing Dextromethorphan, Guaifenesin, Phenylephrine)[§]
    • Tussafed LA® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Tussbid® (as a combination product containing Guaifenesin, Phenylephrine)[§]
    • Tussi Pres® (as a combination product containing Dextromethorphan, Guaifenesin, Phenylephrine)
    • Tussidex® (as a combination product containing Dextromethorphan, Guaifenesin, Phenylephrine)[§]
    • Tussin CF® (as a combination product containing Dextromethorphan, Guaifenesin, Phenylephrine)
    • Tussin DM® (as a combination product containing Dextromethorphan, Guaifenesin)
    • Tylenol Cold and Flu Severe® (as a combination product containing Acetaminophen, Dextromethorphan, Guaifenesin, Phenylephrine)
    • Tylenol Cold Multi-Symptom Severe® (as a combination product containing Acetaminophen, Dextromethorphan, Guaifenesin, Phenylephrine)
    • Tylenol Sinus Congestion and Pain Severe® (as a combination product containing Acetaminophen, Guaifenesin, Phenylephrine)
    • Tylenol Sinus Severe Congestion Daytime® (as a combination product containing Acetaminophen, Guaifenesin, Pseudoephedrine)
    • Vanacof DX® (as a combination product containing Chlophedianol, Guaifenesin, Pseudoephedrine)
    • Vicks DayQuil Mucus Control® (as a combination product containing Guaifenesin)
    • Vicks DayQuil Mucus Control DM® (as a combination product containing Dextromethorphan, Guaifenesin)
    • Vicks Formula 44 Custom Care Chesty Cough® (as a combination product containing Dextromethorphan, Guaifenesin)
    • Vicks VapoSyrup Severe Congestion® (as a combination product containing Guaifenesin, Phenylephrine)
    • Visonex® (as a combination product containing Guaifenesin, Phenylephrine)[§]
    • Wellbid D® (as a combination product containing Guaifenesin, Phenylephrine)[§]
    • Z-Cof DM® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Z-Cof LA® (as a combination product containing Dextromethorphan, Guaifenesin)[§]
    • Z-Dex® (as a combination product containing Dextromethorphan, Guaifenesin, Phenylephrine)
    • Zicam Multi-Symptom Cold and Flu Daytime® (as a combination product containing Acetaminophen, Dextromethorphan, Guaifenesin)
    • Zodryl DEC® (as a combination product containing Codeine, Guaifenesin, Pseudoephedrine)
    • Zotex® (as a combination product containing Dextromethorphan, Guaifenesin, Phenylephrine)[§]
    • Also available generically
    § These products are not currently approved by the FDA for safety, effectiveness, and quality. Federal law generally requires that prescription drugs in the U.S. be shown to be both safe and effective prior to marketing. Please see the FDA website for more information on unapproved drugs ( http://www.fda.gov/AboutFDA/Transparency/Basics/ucm213030.htm) and the approval process ( http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm).
    These branded products are no longer on the market and only generic alternatives are available.

    Acetaminophen, Butalbital, and Caffeine

    (a set a mee' noe fen) (byoo tal' bi tal) (kaf' een)

    IMPORTANT WARNING:

    [Posted 01/13/2011] ISSUE: FDA notified healthcare professionals that it has asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, predominantly combinations of acetaminophen and opioids, to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients. This action will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen. A Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) will be added to the label of all prescription drug products that contain acetaminophen.
    BACKGROUND: Acetaminophen, one of the most commonly used drugs in the United States, is widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain and fever. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet). OTC products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products. No drug shortages are expected, because the 3-year implementation period should permit adequate time for necessary reformulations.
    RECOMMENDATION: Healthcare professionals were reminded to advise patients not to exceed the acetaminophen maximum total daily dose (4 grams/day), and not to drink alcohol while taking acetaminophen-containing medications.
    Healthcare professionals were encouraged to inform patients that there is no immediate danger to patients who take these combination pain medications, and patients should continue to take them as directed by their health care provider. The Drug Safety Communication provides additional information for healthcare professionals, information for patients, a data summary and a list of all affected products. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety .

    WHY is this medicine prescribed?

    This combination of drugs is used to relieve tension headaches.
    This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

    HOW should this medicine be used?

    The combination of acetaminophen, Butalbital, Caffeine comes as a capsule and tablet to take by mouth. It usually is taken every 4 hours as needed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take acetaminophen, Butalbital, Caffeine exactly as directed. Do not take more than six tablets or capsules in 1 day. If you think that you need more to relieve your symptoms, call your doctor.
    This medication can be habit-forming. Do not take a larger dose, take it more often, or for a longer period than your doctor tells you to.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking acetaminophen, Butalbital, Caffeine,
    • tell your doctor and pharmacist if you are allergic to acetaminophen, butalbital, caffeine, or any other drugs.
    • tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially anticoagulants ('blood thinners') such as warfarin (Coumadin), antidepressants, antihistamines, pain medications, sedatives, sleeping pills, tranquilizers, and vitamins. Many nonprescription pain relievers contain acetaminophen. Too much of this drug can be harmful.
    • tell your doctor if you have or have ever had liver disease, porphyria, or depression.
    • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking this medication, call your doctor.
    • you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
    • remember that alcohol can add to the drowsiness caused by this drug.

    What SPECIAL DIETARY instructions should I follow?

    Acetaminophen, Butalbital, Caffeine may cause an upset stomach. Take this medicine with food or milk.

    What should I do IF I FORGET to take a dose?

    Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

    What SIDE EFFECTS can this medicine cause?

    Acetaminophen, Butalbital, Caffeine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
    • drowsiness
    • upset stomach
    • vomiting
    • stomach pain
    • depression
    • lightheadedness
    • confusion
    If you experience any of the following symptoms, call your doctor immediately:
    • skin rash
    • itching
    • difficulty breathing
    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

    What OTHER INFORMATION should I know?

    Keep all appointments with your doctor.
    Do not let anyone else take your medication. This medication is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.
    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    Brand Names

    • Alagesic® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Americet® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Anolor® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Anoquan® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Arcet® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Dolgic® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Dolmar® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Endolor® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Esgic® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Ezol® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Femcet® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Fioricet® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Fiorpap® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • G-1® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Geone® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Ide-cet® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Isocet® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Margesic® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Medigesic® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Minotal® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Mygracet® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Nonbac® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Orbivan® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Pacaps® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Pharmagesic® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Quala Cet® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Repan® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Tenake® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Tencet® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Triad® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Two-Dyne® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Zebutal® (as a combination product containing Acetaminophen, Butalbital, Caffeine)
    • Fioricet® with Codeine (as a combination product containing Acetaminophen, Butalbital, Caffeine, Codeine)
    • Phrenilin® with Caffeine and Codeine (as a combination product containing Acetaminophen, Butalbital, Caffeine, Codeine)

    Chlorpheniramine

    (klor fen ir' a meen)

    IMPORTANT WARNING:

    FDA Intends to Remove Some Unapproved Cough, Cold, and Allergy Drugs from the Market

    This safety alert does not apply to this medication, but only to some products which contain this medication. In addition, it is important that you know that there is not a problem with most of the products described in this medication monograph. And some drug companies may decide to seek full approval from the FDA so that they can continue marketing their products.
    On March 2, 2011, the Food and Drug Administration (FDA) issued a safety alert about certain unapproved prescription cough, cold, and allergy products containing this drug in combination with other drugs. These products are not currently approved by the FDA for safety, effectiveness, and quality. FDA asked drug companies to stop shipping most of these products for sale in the US within the next 6 months. Although some of these products have been marketed for many years, laws about what a company must prove to FDA for drug product approval have gotten tougher and increased enforcement of these laws is now taking place. The FDA took this action due to concerns about certain potential risks associated with use of these medications. These risks may include:
    • the possibility of improper use in infants and young children
    • potentially risky combinations of ingredients
    • patients receiving too much or too little of the medication because of problems with the way some ''timed-release'' products are made
    If you are concerned that the prescription cough, cold, and allergy medication you are taking is not approved by the FDA, you should talk to your doctor or pharmacist. If the medication you are taking is not approved, your doctor can prescribe another prescription medication or your doctor or pharmacist can suggest an over-the-counter (OTC) cough, cold, and allergy product for your condition. There are many safe and effective alternative approved products that can be taken instead. Your doctor probably prescribed the medicine without knowing that FDA had not approved it. This is because it has been so difficult for doctors and pharmacists to find out that these products are unapproved. For additional information:

    WHY is this medicine prescribed?

    Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

    HOW should this medicine be used?

    Chlorpheniramine comes as a tablet, a capsule, an extended-release (long-acting) tablet and capsule, a chewable tablet, and a liquid to take by mouth. The regular capsules and tablets, chewable tablets, and liquid are usually taken every 4 to 6 hours as needed. The extended-release (long-acting) tablets and capsules are usually taken twice a day in the morning and evening as needed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take chlorpheniramine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
    Chlorpheniramine comes alone and in combination with fever and pain reducers, expectorants, cough suppressants, and decongestants. Ask your doctor or pharmacist for advice on which product is best for your symptoms. Check nonprescription cough and cold product labels carefully before using 2 or more products at the same time. These products may contain the same active ingredient(s) and taking them together could cause you to receive an overdose.This is especially important if you will be giving cough and cold medications to a child.
    Nonprescription cough and cold combination products, including products that contain chlorpheniramine, can cause serious side effects or death in young children. Do not give these products to children younger than 4 years of age. If you give these products to children 4-11 years of age, use caution and follow the package directions carefully.
    If you are giving chlorpheniramine or a combination product that contains chlorpheniramine to a child, read the package label carefully to be sure that it is the right product for a child of that age. Do not give chlorpheniramine products that are made for adults to children.
    Before you give a chlorpheniramine product to a child, check the package label to find out how much medication the child should receive. Give the dose that matches the child's age on the chart. Ask the child's doctor if you don't know how much medication to give the child.
    If you are taking the liquid, do not use a household spoon to measure your dose. Use the measuring spoon or cup that came with the medication or use a spoon made especially for measuring medication.
    If you are using the extended-release tablets or capsules, swallow them whole. Do not break, crush, chew, or open them.

    Are there OTHER USES for this medicine?

    This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking chlorpheniramine,
    • tell your doctor and pharmacist if you are allergic to chlorpheniramine, any other medications, or any of the ingredients in the chlorpheniramine product you plan to use. Check the package label for a list of the ingredients.
    • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: other medications for colds, hay fever, or allergies; medications for anxiety, depression, or seizures; muscle relaxants; narcotic medications for pain; sedatives; sleeping pills; and tranquilizers.
    • tell your doctor if you have or have ever had asthma, emphysema, chronic bronchitis, or other types of lung disease; glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision); ulcers; diabetes; difficulty urinating (due to an enlarged prostate gland); heart disease; high blood pressure; seizures; or an overactive thyroid gland.
    • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking chlorpheniramine, call your doctor.
    • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking chlorpheniramine.
    • you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
    • ask your doctor about the safe use of alcohol while you are taking chlorpheniramine. Alcohol can make the side effects of chlorpheniramine worse.

    What SPECIAL DIETARY instructions should I follow?

    Unless your doctor tells you otherwise, continue your normal diet.

    What should I do IF I FORGET to take a dose?

    Chlorpheniramine is usually taken as needed. If your doctor has told you to take chlorpheniramine regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

    What SIDE EFFECTS can this medicine cause?

    Chlorpheniramine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
    • drowsiness
    • dry mouth, nose, and throat
    • nausea
    • vomiting
    • loss of appetite
    • constipation
    • headache
    • increased chest congestion
    Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
    • vision problems
    • difficulty urinating
    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

    What OTHER INFORMATION should I know?

    Ask your pharmacist any questions you have about chlorpheniramine.
    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    Brand Names

    • Aller-Chlor®[¶]
    • Allerlief®[¶]
    • Chlorphen-12®
    • Chlor-Trimeton Allergy®
    • Pediatan®[¶]
    • Ridramin®[¶]
    • TanaHist PD®[§]
    • Teldrin HBP®
    • AccuHist® (as a combination product containing Chlorpheniramine, Phenylephrine)
    • Actifed Cold and Allergy® (as a combination product containing Chlorpheniramine, Phenylephrine)
    • Advil Allergy Sinus® (as a combination product containing Chlorpheniramine, Ibuprofen, Pseudoephedrine)
    • Aerohist® (as a combination product containing Chlorpheniramine, Methscopolamine)[§]
    • Aerohist Plus® (as a combination product containing Chlorpheniramine, Methscopolamine, Phenylephrine)[§]
    • Aerokid® (as a combination product containing Chlorpheniramine, Methscopolamine, Phenylephrine)[¶]
    • Ah Chew® (as a combination product containing Chlorpheniramine, Phenylephrine)[§]
    • Ah Chew Ultra® (as a combination product containing Chlorpheniramine, Phenylephrine, Methscopolamine)[§]
    • Alka-Seltzer Plus Cold and Cough Formula® (as a combination product containing Aspirin, Chlorpheniramine, Dextromethorphan, Phenylephrine)
    • Alka-Seltzer Plus Fast Powder Packs® (as a combination product containing Acetaminophen, Chlorpheniramine, Phenylephrine)
    • Alka-Seltzer Plus Flu Formula® (as a combination product containing Acetaminophen, Chlorpheniramine, Dextromethorphan, Phenylephrine)
    • Alka-Seltzer Plus Sparkling Original Cold Formula® (as a combination product containing Aspirin, Chlorpheniramine, Phenylephrine)
    • Allerest PE® (as a combination product containing Chlorpheniramine, Phenylephrine)
    • Allergy DN II® (as a combination product containing Chlorpheniramine, Methscopolamine)[§]
    • Allergy DN PE® (as a combination product containing Chlorpheniramine, Methscopolamine, Phenylephrine)[§]
    • AllerTan® (as a combination product containing Chlorpheniramine, Phenylephrine, Pyrilamine)[¶]
    • AlleRx® (as a combination product containing Chlorpheniramine, Phenylephrine)[§]
    • Amerituss AD® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)[¶]
    • Atrohist® (as a combination product containing Chlorpheniramine, Phenylephrine, Pyrilamine)[¶]
    • Atuss DM® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)[¶]
    • Atuss HD® (as a combination product containing Chlorpheniramine, Hydrocodone, Phenylephrine)[¶]
    • Baltussin HC® (as a combination product containing Chlorpheniramine, Hydrocodone, Phenylephrine)[¶]
    • Broncopectol® (as a combination product containing Chlorpheniramine, Dextromethorphan, Guaifenesin, Phenylephrine)[¶]
    • Bronkids® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)[§]
    • Bronkotuss® (as a combination product containing Chlorpheniramine, Ephedrine, Guaifenesin)[¶]
    • C Phen® (as a combination product containing Chlorpheniramine, Phenylephrine)[§]
    • C Phen DM® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)[§]
    • Cardec DM® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)
    • Centergy® (as a combination product containing Chlorpheniramine, Phenylephrine)[§]
    • Centergy DM® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)[§]
    • Ceron® (as a combination product containing Chlorpheniramine, Phenylephrine)
    • Ceron DM® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)[§]
    • Cerose DM® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)[¶]
    • Children's Dimetapp Long Acting Cough Plus Cold® (as a combination product containing Chlorpheniramine, Dextromethorphan)
    • Children's Dimetapp Multisymptom Cold and Flu® (as a combination product containing Acetaminophen, Chlorpheniramine, Dextromethorphan, Phenylephrine)
    • Children's Robitussin Cough and Cold Long-Acting® (as a combination product containing Chlorpheniramine, Dextromethorphan)
    • Chlordex GP® (as a combination product containing Chlorpheniramine, Dextromethorphan, Guaifenesin, Phenylephrine)[§]
    • Chlorfed A SR® (as a combination product containing Chlorpheniramine, Pseudoephedrine)[§]
    • Coldamine® (as a combination product containing Chlorpheniramine, Methscopolamine, Pseudoephedrine)[§]
    • Colfed A® (as a combination product containing Chlorpheniramine, Pseudoephedrine)[§]
    • Colrex® (as a combination product containing Acetaminophen, Chlorpheniramine, Codeine, Phenylephrine)[¶]
    • Comhist® (as a combination product containing Chlorpheniramine, Phenylephrine, phenyltoloxamine)[¶]
    • Comtrex Cold and Cough Day/Night® (as a combination product containing Acetaminophen, Chlorpheniramine, Dextromethorphan, Phenylephrine)
    • Conal® (as a combination product containing Chlorpheniramine, Phenylephrine, Pyrilamine)[¶]
    • Contac Cold and Flu Maximum Strength® (as a combination product containing Acetaminophen, Chlorpheniramine, Phenylephrine)[¶]
    • Corfen DM® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)
    • Coricidin® (as a combination product containing Acetaminophen, Chlorpheniramine)
    • Coricidin HBP Cold and Flu® (as a combination product containing Acetaminophen, Chlorpheniramine)
    • Coricidin HBP Cough and Cold® (as a combination product containing Chlorpheniramine, Dextromethorphan)
    • Coricidin HBP Day and Night Multi-Symptom Cold® (as a combination product containing Acetaminophen, Chlorpheniramine, Dextromethorphan, Guaifenesin)
    • Coricidin HBP Maximum Strength Flu® (as a combination product containing Acetaminophen, Chlorpheniramine, Dextromethorphan)
    • Dallergy Drops® (as a combination product containing Chlorpheniramine, Phenylephrine)
    • Dallergy PE® (as a combination product containing Chlorpheniramine, Methscopolamine, Phenylephrine)[§]
    • Dallergy PSE® (as a combination product containing Chlorpheniramine, Methscopolamine, Pseudoephedrine)[§]
    • Deconamine® (as a combination product containing Chlorpheniramine, Pseudoephedrine)[§]
    • Deconomed SR® (as a combination product containing Chlorpheniramine, Pseudoephedrine)[§]
    • Dehistine® (as a combination product containing Chlorpheniramine, Methscopolamine, Phenylephrine)[§]
    • Dexodryl® (as a combination product containing Chlorpheniramine)[§]
    • Donatussin DM® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)
    • Dristan Cold Multi-Symptom Formula® (as a combination product containing Acetaminophen, Chlorpheniramine, Phenylephrine)
    • Drymax® (as a combination product containing Chlorpheniramine, Methscopolamine, Pseudoephedrine)[§]
    • Dynahist ER® (as a combination product containing Chlorpheniramine, Pseudoephedrine)[§]
    • EndaCof-C® (as a combination product containing Chlorpheniramine, Codeine)[§]
    • Endal CD® (as a combination product containing Chlorpheniramine, Codeine, Phenylephrine)
    • Extendryl® (as a combination product containing Chlorpheniramine, Methscopolamine, Phenylephrine)[§]
    • Guaidex TR® (as a combination product containing Chlorpheniramine, Dextromethorphan, Guaifenesin, Methscopolamine, Pseudoephedrine)[§]
    • Histadec® (as a combination product containing Chlorpheniramine, Phenylephrine)[¶]
    • Histex® (as a combination product containing Chlorpheniramine, Pseudoephedrine)[§]
    • Histinex HC® (as a combination product containing Chlorpheniramine, Hydrocodone, Phenylephrine)[¶]
    • Hycomine Compound® (as a combination product containing Acetaminophen, Caffeine, Chlorpheniramine, Hydrocodone, Phenylephrine)[¶]
    • LoHist-D® (as a combination product containing Chlorpheniramine, Pseudoephedrine)[§]
    • Maxichlor® (as a combination product containing Chlorpheniramine, Dextromethorphan)[¶]
    • Maxiphen ADT® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)[§]
    • Mintex® (as a combination product containing Chlorpheniramine, Pseudoephedrine)[§]
    • Mintuss DR® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)[§]
    • Nasohist® (as a combination product containing Chlorpheniramine, Phenylephrine)
    • Nasohist DM® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)
    • Neo DM® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)[§]
    • Neutrahist® (as a combination product containing Chlorpheniramine, Pseudoephedrine)[§]
    • NoHist® (as a combination product containing Chlorpheniramine, Phenylephrine)[§]
    • NoHist-DM® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)
    • NoHist-LQ® (as a combination product containing Chlorpheniramine, Phenylephrine)
    • Norel DM® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)[§]
    • Norel SR® (as a combination product containing Acetaminophen, Chlorpheniramine, Phenylephrine, Phenyltoloxamine)[§]
    • Novahistine® (as a combination product containing Chlorpheniramine, Phenylephrine)[¶]
    • Omnihist II LA® (as a combination product containing Chlorpheniramine, Methscopolamine, Phenylephrine)[§]
    • PediaCare Children's Fever Reducer Plus Cough and Runny Nose® (as a combination product containing Acetaminophen, Chlorpheniramine, Dextromethorphan)
    • PediaCare Children's Fever Reducer Plus Flu® (as a combination product containing Acetaminophen, Chlorpheniramine, Dextromethorphan, Phenylephrine)
    • PediaCare Children's Fever Reducer Plus Multi-Symptom Cold® (as a combination product containing Acetaminophen, Chlorpheniramine, Dextromethorphan, Phenylephrine)
    • Pediacof® (as a combination product containing Chlorpheniramine, Codeine, Phenylephrine, Potassium Iodide)[¶]
    • Phenabid® (as a combination product containing Chlorpheniramine, Phenylephrine)[§]
    • Poly Hist PD® (as a combination product containing Chlorpheniramine, Phenylephrine, Pyrilamine)[§]
    • Poly-Tussin DM® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)
    • Protid® (as a combination product containing Acetaminophen, Chlorpheniramine, Phenylephrine)[¶]
    • Pyrlex CB® (as a combination product containing Chlorpheniramine, Pyrilamine)[§]
    • Quartuss® (as a combination product containing Chlorpheniramine, Dextromethorphan, Guaifenesin, Phenylephrine)[§]
    • Quartuss DM® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)[§]
    • Re Allergy AM/PM® (as a combination product containing Chlorpheniramine, Methscopolamine, Phenylephrine)[§]
    • Redur PCM® (as a combination product containing Chlorpheniramine, Phenylephrine)[§]
    • Relcof CPM® (as a combination product containing Chlorpheniramine, Methscopolamine)[§]
    • Relcof PE® (as a combination product containing Chlorpheniramine, Methscopolamine, Phenylephrine)[§]
    • Relcof PSE® (as a combination product containing Chlorpheniramine, Methscopolamine, Pseudoephedrine)[§]
    • RemeTussin DM® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)[§]
    • Rescon® (as a combination product containing Chlorpheniramine, Methscopolamine, Phenylephrine)[§]
    • Respivent D® (as a combination product containing Chlorpheniramine, Methscopolamine, Pseudoephedrine)[§]
    • Robitussin Cough and Cold Long-Acting® (as a combination product containing Chlorpheniramine, Dextromethorphan)
    • Robitussin Night Time Cough, Cold, and Flu® (as a combination product containing Acetaminophen, Chlorpheniramine, Dextromethorphan, Phenylephrine)
    • Rolatuss® (as a combination product containing Ammonium Chloride, Chlorpheniramine, Codeine, Phenylephrine)[¶]
    • Rondex® (as a combination product containing Chlorpheniramine, Phenylephrine)[¶]
    • R-Tanna® (as a combination product containing Chlorpheniramine, Phenylephrine)[§]
    • Rynatan® (as a combination product containing Chlorpheniramine, Phenylephrine)[§]
    • Rynatuss® (as a combination product containing Carbetapentane, Chlorpheniramine, Ephedrine, Phenylephrine)[§]
    • Ryneze® (as a combination product containing Chlorpheniramine, Methscopolamine)[¶]
    • Ryneze® (as a combination product containing Chlorpheniramine, Methscopolamine)[§]
    • Ry-Tuss® (as a combination product containing Carbetapentane, Chlorpheniramine, Ephedrine, Phenylephrine)[§]
    • ScopoHist® (as a combination product containing Chlorpheniramine, Methscopolamine, Phenylephrine)[§]
    • Sildec PE DM® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)[§]
    • Sine-Off Cough/Cold® (as a combination product containing Acetaminophen, Dextromethorphan, Guaifenesin, Phenylephrine)
    • Sine-Off Sinus/Cold® (as a combination product containing Acetaminophen, Chlorpheniramine, Phenylephrine)
    • Sonahist® (as a combination product containing Chlorpheniramine, Phenylephrine)[§]
    • Sonahist DM® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)[§]
    • Statuss DM® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)[§]
    • Suclor® (as a combination product containing Chlorpheniramine, Pseudoephedrine)[§]
    • Sudafed PE Sinus/Allergy® (as a combination product containing Chlorpheniramine, Phenylephrine)
    • Sudahist® (as a combination product containing Chlorpheniramine, Pseudoephedrine)[§]
    • Sympak PDX® (as a combination product containing Chlorpheniramine, Methscopolamine, Phenylephrine)[§]
    • Triall® (as a combination product containing Chlorpheniramine, Methscopolamine, Phenylephrine)[§]
    • Triaminic Cold and Allergy® (as a combination product containing Chlorpheniramine, Phenylephrine)
    • Triaminic Multi-Symptom Fever® (as a combination product containing Acetaminophen, Chlorpheniramine, Dextromethorphan)
    • Trital DM® (as a combination product containing Chlorpheniramine, Dextromethorphan, Phenylephrine)[§]
    • Tussionex® (as a combination product containing Chlorpheniramine, Hydrocodone)
    • Tylenol Allergy Multi-Symptom® (as a combination product containing Acetaminophen, Chlorpheniramine, Phenylephrine)
    • Tylenol Cold Multi-Symptom Nighttime® (as a combination product containing Acetaminophen, Chlorpheniramine, Dextromethorphan, Phenylephrine)
    • Tylenol Sinus Congestion and Pain Nighttime® (as a combination product containing Acetaminophen, Chlorpheniramine, Phenylephrine)
    • Vanex-HD® (as a combination product containing Chlorpheniramine, Hydrocodone, Phenylephrine)[¶]
    • Vicks Children's NyQuil Cold and Flu® (as a combination product containing Chlorpheniramine, Dextromethorphan)
    • Vicks Formula 44 Custom Care Cough and Cold PM® (as a combination product containing Acetaminophen, Chlorpheniramine, Dextromethorphan)
    • VisRx® (as a combination product containing Chlorpheniramine, Methscopolamine)[§]
    • Zodryl AC® (as a combination product containing Chlorpheniramine, Codeine)
    • Zutripro® (as a combination product containing Chlorpheniramine, Hydrocodone, Pseudoephedrine)
    • Also available generically
    § These products are not currently approved by the FDA for safety, effectiveness, and quality. Federal law generally requires that prescription drugs in the U.S. be shown to be both safe and effective prior to marketing. Please see the FDA website for more information on unapproved drugs ( http://www.fda.gov/AboutFDA/Transparency/Basics/ucm213030.htm) and the approval process ( http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm).
    These branded products are no longer on the market and only generic alternatives are available.

    Aspirin

    (as' pir in)

    WHY is this medicine prescribed?

    Prescription aspirin is used to relieve the symptoms of rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), osteoarthritis (arthritis caused by breakdown of the lining of the joints), systemic lupus erythematosus (condition in which the immune system attacks the joints and organs and causes pain and swelling) and certain other rheumatologic conditions (conditions in which the immune system attacks parts of the body). Nonprescription aspirin is used to reduce fever and to relieve mild to moderate pain from headaches, menstrual periods, arthritis, colds, toothaches, and muscle aches. Nonprescription aspirin is also used to prevent heart attacks in people who have had a heart attack in the past or who have angina (chest pain that occurs when the heart does not get enough oxygen). Nonprescription aspirin is also used to reduce the risk of death in people who are experiencing or who have recently experienced a heart attack. Nonprescription aspirin is also used to prevent ischemic strokes (strokes that occur when a blood clot blocks the flow of blood to the brain) or mini-strokes (strokes that occur when the flow of blood to the brain is blocked for a short time) in people who have had this type of stroke or mini-stroke in the past. Aspirin will not prevent hemorrhagic strokes (strokes caused by bleeding in the brain). Aspirin is in a group of medications called salicylates. It works by stopping the production of certain natural substances that cause fever, pain, swelling, and blood clots.
    Aspirin is also available in combination with other medications such as antacids, pain relievers, and cough and cold medications. This monograph only includes information about the use of aspirin alone. If you are taking a combination product, read the information on the package or prescription label or ask your doctor or pharmacist for more information.

    HOW should this medicine be used?

    Prescription aspirin comes as an extended-release tablet (tablet that releases medication slowly over a period of time). Nonprescription aspirin comes as a regular tablet, an enteric-coated, delayed-release tablet (tablet that first begins to release medication some time after it is taken), a chewable tablet, powder, and a gum to take by mouth and a suppository to use rectally. Prescription aspirin is usually taken two or more times a day. Nonprescription aspirin is usually taken once a day to lower the risk of a heart attack or stroke. Nonprescription aspirin is usually taken every 4 to 6 hours as needed to treat fever or pain. Follow the directions on the package or prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take aspirin exactly as directed. Do not take more or less of it or take it more often than directed by the package label or prescribed by your doctor.
    Swallow the extended-release tablets whole with a full glass of water. Do not break, crush, or chew them.
    Swallow the tablets with a full glass of water.
    Chewable aspirin tablets may be chewed, crushed, or swallowed whole. Drink a full glass of water, immediately after taking these tablets.
    Ask a doctor before you give aspirin to your child or teenager. Aspirin may cause Reye's syndrome (a serious condition in which fat builds up on the brain, liver, and other body organs) in children and teenagers, especially if they have a virus such as chicken pox or the flu.
    If you have had oral surgery or surgery to remove your tonsils in the last 7 days, talk to your doctor about which types of aspirin are safe for you.
    Delayed-release tablets begin to work some time after they are taken. Do not take delayed-release tablets for fever or pain that must be relieved quickly.
    Stop taking aspirin and call your doctor if your fever lasts longer than 3 days, if your pain lasts longer than 10 days, or if the part of your body that was painful becomes red or swollen. You may have a condition that must be treated by a doctor.
    To insert an aspirin suppository into the rectum, follow these steps:
    1. Remove the wrapper.
    2. Dip the tip of the suppository in water.
    3. Lie down on your left side and raise your right knee to your chest. (If you are left-handed, lie on your right side and raise your left knee.)
    4. Using your finger, insert the suppository into the rectum, about 1/2 to 1 inch (1.25 to 2.5 centimeters) in infants and children and 1 inch (2.5 centimeters) in adults. Hold it in place for a few moments.
    5. Do not stand up for at least 15 minutes. Then wash your hands thoroughly and resume your normal activities.

    Are there OTHER USES for this medicine?

    Aspirin is also sometimes used to treat rheumatic fever (a serious condition that may develop after a strep throat infection and may cause swelling of the heart valves) and Kawasaki disease (an illness that may cause heart problems in children). Aspirin is also sometimes used to lower the risk of blood clots in patients who have artificial heart valves or certain other heart conditions and to prevent certain complications of pregnancy.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking aspirin,
    • tell your doctor and pharmacist if you are allergic to aspirin, other medications for pain or fever, tartrazine dye, or any other medications.
    • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: acetazolamide (Diamox); angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril, (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); anticoagulants ('blood thinners') such as warfarin (Coumadin) and heparin; beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); diuretics ('water pills'); medications for diabetes or arthritis; medications for gout such as probenecid and sulfinpyrazone (Anturane); methotrexate (Trexall); other nonsteroidal anti-inflammatory drugs (NSAIDs) such as naproxen (Aleve, Naprosyn); phenytoin (Dilantin); and valproic acid (Depakene, Depakote). Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
    • if you are taking aspirin on a regular basis to prevent heart attack or stroke, do not take ibuprofen (Advil, Motrin) to treat pain or fever without talking to your doctor. Your doctor will probably tell you to allow some time to pass between taking your daily dose of aspirin and taking a dose of ibuprofen.
    • tell your doctor if you have or have ever had asthma, frequent stuffed or runny nose, or nasal polyps (growths on the linings of the nose). If you have these conditions, there is a risk that you will have an allergic reaction to aspirin. Your doctor may tell you that you should not take aspirin.
    • tell your doctor if you often have heartburn, upset stomach, or stomach pain and if you have or have ever had ulcers, anemia, bleeding problems such as hemophilia, or kidney or liver disease.
    • tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, you plan to become pregnant, or you are breast-feeding. If you become pregnant while taking aspirin, call your doctor. Aspirin may harm the fetus and cause problems with delivery if it is taken during the last few months of pregnancy.
    • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking aspirin.
    • if you drink three or more alcoholic drinks every day, ask your doctor if you should take aspirin or other medications for pain and fever.

    What SPECIAL DIETARY instructions should I follow?

    Unless your doctor tells you otherwise, continue your normal diet.

    What should I do IF I FORGET to take a dose?

    If your doctor has told you to take aspirin on a regular basis and you miss a dose, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

    What SIDE EFFECTS can this medicine cause?

    Aspirin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
    • nausea
    • vomiting
    • stomach pain
    • heartburn
    Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
    • hives
    • rash
    • swelling of the eyes, face, lips, tongue, or throat
    • wheezing or difficulty breathing
    • hoarseness
    • fast heartbeat
    • fast breathing
    • cold, clammy skin
    • ringing in the ears
    • loss of hearing
    • bloody vomit
    • vomit that looks like coffee grounds
    • bright red blood in stools
    • black or tarry stools
    Aspirin may cause other side effects. Call your doctor if you experience any unusual problems while you are taking this medication.
    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Store aspirin suppositories in a cool place or in a refrigerator. Throw away any medication that is outdated or no longer needed and any tablets that have a strong vinegar smell. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
    Symptoms of overdose may include:
    • burning pain in the throat or stomach
    • vomiting
    • decreased urination
    • fever
    • restlessness
    • irritability
    • talking a lot and saying things that do not make sense
    • fear or nervousness
    • dizziness
    • double vision
    • uncontrollable shaking of a part of the body
    • confusion
    • abnormally excited mood
    • hallucination (seeing things or hearing voices that are not there)
    • seizures
    • drowsiness
    • loss of consciousness for a period of time

    What OTHER INFORMATION should I know?

    Keep all appointments with your doctor.
    If you are taking prescription aspirin, do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    Brand Names

    • Acuprin®
    • Anacin® Aspirin Regimen
    • Ascriptin®
    • Aspergum®
    • Aspidrox®
    • Aspir-Mox®
    • Aspirtab®
    • Aspir-trin®
    • Bayer® Aspirin
    • Bufferin®
    • Buffex®
    • Easprin®
    • Ecotrin®
    • Empirin®
    • Entaprin®
    • Entercote®
    • Fasprin®
    • Genacote®
    • Gennin-FC®
    • Genprin®
    • Halfprin®
    • Magnaprin®
    • Miniprin®
    • Minitabs®
    • Ridiprin®
    • Sloprin®
    • Uni-Buff®
    • Uni-Tren®
    • Valomag®
    • Zorprin®
    • Alka-Seltzer® (as a combination product containing Aspirin, Citric Acid, Sodium Bicarbonate)
    • Alka-Seltzer® Extra Strength (as a combination product containing Aspirin, Citric Acid, Sodium Bicarbonate)
    • Alka-Seltzer® Morning Relief (as a combination product containing Aspirin, Caffeine)
    • Alka-Seltzer® Plus Flu (as a combination product containing Aspirin, Chlorpheniramine, Dextromethorphan)
    • Alka-Seltzer® PM (as a combination product containing Aspirin, Diphenhydramine)
    • Alor® (as a combination product containing Aspirin, Hydrocodone)
    • Anacin® (as a combination product containing Aspirin, Caffeine)
    • Anacin® Advanced Headache Formula (as a combination product containing Acetaminophen, Aspirin, Caffeine)
    • Aspircaf® (as a combination product containing Aspirin, Caffeine)
    • Axotal® (as a combination product containing Aspirin, Butalbital)
    • Azdone® (as a combination product containing Aspirin, Hydrocodone)
    • Bayer® Aspirin Plus Calcium (as a combination product containing Aspirin, Calcium Carbonate)
    • Bayer® Aspirin PM (as a combination product containing Aspirin, Diphenhydramine)
    • Bayer® Back and Body Pain (as a combination product containing Aspirin, Caffeine)
    • BC Headache (as a combination product containing Aspirin, Caffeine, Salicylamide)
    • BC Powder (as a combination product containing Aspirin, Caffeine, Salicylamide)
    • Damason-P® (as a combination product containing Aspirin, Hydrocodone)
    • Emagrin® (as a combination product containing Aspirin, Caffeine, Salicylamide)
    • Endodan® (as a combination product containing Aspirin, Oxycodone)
    • Equagesic® (as a combination product containing Aspirin, Meprobamate)
    • Excedrin® (as a combination product containing Acetaminophen, Aspirin, Caffeine)
    • Excedrin® Back & Body (as a combination product containing Acetaminophen, Aspirin)
    • Goody's® Body Pain (as a combination product containing Acetaminophen, Aspirin)
    • Levacet® (as a combination product containing Acetaminophen, Aspirin, Caffeine, Salicylamide)
    • Lortab ASA® (as a combination product containing Aspirin, Hydrocodone)
    • Micrainin® (as a combination product containing Aspirin, Meprobamate)
    • Momentum® (as a combination product containing Aspirin, Phenyltoloxamine)
    • Norgesic® (as a combination product containing Aspirin, Caffeine, Orphenadrine)
    • Orphengesic® (as a combination product containing Aspirin, Caffeine, Orphenadrine)
    • Panasal® (as a combination product containing Aspirin, Hydrocodone)
    • Percodan® (as a combination product containing Aspirin, Oxycodone)
    • Robaxisal® (as a combination product containing Aspirin, Methocarbamol)
    • Roxiprin® (as a combination product containing Aspirin, Oxycodone)
    • Saleto® (as a combination product containing Acetaminophen, Aspirin, Caffeine, Salicylamide)
    • Soma® Compound (as a combination product containing Aspirin, Carisoprodol)
    • Soma® Compound with Codeine (as a combination product containing Aspirin, Carisoprodol, Codeine)
    • Supac® (as a combination product containing Acetaminophen, Aspirin, Caffeine)
    • Synalgos-DC® (as a combination product containing Aspirin, Caffeine, Dihydrocodeine)
    • Talwin® Compound (as a combination product containing Aspirin, Pentazocine)
    • Vanquish® (as a combination product containing Acetaminophen, Aspirin, Caffeine)
    • Also available generically

    Other Names

    • Acetylsalicylic acid
    • ASA

    Pseudoephedrine

    (soo doe e fed' rin)

    IMPORTANT WARNING:

    FDA Intends to Remove Some Unapproved Cough, Cold, and Allergy Drugs from the Market

    This safety alert does not apply to this medication, but only to some products which contain this medication. In addition, it is important that you know that there is not a problem with most of the products described in this medication monograph. And some drug companies may decide to seek full approval from the FDA so that they can continue marketing their products.
    On March 2, 2011, the Food and Drug Administration (FDA) issued a safety alert about certain unapproved prescription cough, cold, and allergy products containing this drug in combination with other drugs. These products are not currently approved by the FDA for safety, effectiveness, and quality. FDA asked drug companies to stop shipping most of these products for sale in the US within the next 6 months. Although some of these products have been marketed for many years, laws about what a company must prove to FDA for drug product approval have gotten tougher and increased enforcement of these laws is now taking place. The FDA took this action due to concerns about certain potential risks associated with use of these medications. These risks may include:
    • the possibility of improper use in infants and young children
    • potentially risky combinations of ingredients
    • patients receiving too much or too little of the medication because of problems with the way some ''timed-release'' products are made
    If you are concerned that the prescription cough, cold, and allergy medication you are taking is not approved by the FDA, you should talk to your doctor or pharmacist. If the medication you are taking is not approved, your doctor can prescribe another prescription medication or your doctor or pharmacist can suggest an over-the-counter (OTC) cough, cold, and allergy product for your condition. There are many safe and effective alternative approved products that can be taken instead. Your doctor probably prescribed the medicine without knowing that FDA had not approved it. This is because it has been so difficult for doctors and pharmacists to find out that these products are unapproved. For additional information:

    WHY is this medicine prescribed?

    Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.

    HOW should this medicine be used?

    Pseudoephedrine comes as a regular tablet, a 12-hour extended-release (long-acting) tablet, a 24-hour extended-release tablet, and a solution (liquid) to be taken by mouth. The regular tablets and liquid are usually taken every 4 to 6 hours. The 12-hour extended-release tablets usually are taken every 12 hours, and you should not take more than two doses in a 24-hour period. The 24-hour extended-release tablets usually are taken once a day, and you should not take more than one dose in a 24-hour period. To help prevent trouble sleeping, take the last dose of the day several hours before bedtime. Follow the directions on the package label or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take pseudoephedrine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor or directed on the label.
    Pseudoephedrine comes alone and in combination with other medications. Ask your doctor or pharmacist for advice on which product is best for your symptoms. Check nonprescription cough and cold product labels carefully before using 2 or more products at the same time. These products may contain the same active ingredient(s) and taking them together could cause you to receive an overdose. This is especially important if you will be giving cough and cold medications to a child.
    Nonprescription cough and cold combination products, including products that contain pseudoephedrine, can cause serious side effects or death in young children. Do not give other nonprescription pseudoephedrine products to children younger than 4 years of age. If you give these products to children 4-11 years of age, use caution and follow the package directions carefully. Do not give pseudoephedrine extended-release tablets to children younger than 12 years of age.
    If you are giving pseudoephedrine or a combination product that contains pseudoephedrine to a child, read the package label carefully to be sure that it is the right product for a child of that age. Do not give pseudoephedrine products that are made for adults to children.
    Before you give a pseudoephedrine product to a child, check the package label to find out how much medication the child should receive. Give the dose that matches the child's age on the chart. Ask the child's doctor if you don't know how much medication to give the child.
    If you are taking the liquid, do not use a household spoon to measure your dose. Use the measuring spoon or cup that came with the medication or use a spoon made especially for measuring medication.
    If your symptoms do not get better within 7 days or if you have a fever, stop taking pseudoephedrine and call your doctor.
    Swallow the extended-release tablets whole; do not break, crush, or chew them.

    Are there OTHER USES for this medicine?

    This medication is also sometimes used to prevent ear pain and blockage caused by pressure changes during air travel or underwater diving. Talk to your doctor or pharmacist for more information.
    This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking pseudoephedrine,
    • tell your doctor and pharmacist if you are allergic to pseudoephedrine, any other medications, or any of the inactive ingredients in the pseudoephedrine product you plan to take. Check the package label for a list of the ingredients.
    • do not take pseudoephedrine if you are taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking one of these medications within the past 2 weeks.
    • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention medications for diet or appetite control, asthma, colds, or high blood pressure.
    • tell your doctor if you have or have ever had high blood pressure, glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision), diabetes, difficulty urinating (due to an enlarged prostate gland), or thyroid or heart disease. If you plan to take the 24-hour extended-release tablets, tell your doctor if you have had a narrowing or blockage of your digestive system.
    • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking pseudoephedrine, call your doctor.
    • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking pseudoephedrine.

    What SPECIAL DIETARY instructions should I follow?

    Foods and drinks that contain large amounts of caffeine can make the side effects of pseudoephedrine worse.

    What should I do IF I FORGET to take a dose?

    This medication is usually taken as needed. If your doctor has told you to take pseudoephedrine regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

    What SIDE EFFECTS can this medicine cause?

    Pseudoephedrine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
    • restlessness
    • nausea
    • vomiting
    • weakness
    • headache
    Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
    • nervousness
    • dizziness
    • difficulty sleeping
    • stomach pain
    • difficulty breathing
    • fast, pounding, or irregular heartbeat
    Pseudoephedrine may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

    What OTHER INFORMATION should I know?

    If you are taking the 24-hour extended-release tablets, you may notice something that looks like a tablet in your stool. This is just the empty tablet shell, and this does not mean that you did not get your complete dose of medication.
    Ask your pharmacist any questions you have about pseudoephedrine.
    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    Brand Names

    • Afrinol®[¶]
    • Cenafed®[¶]
    • Children's Sudafed Nasal Decongestant®
    • Congestaclear®[¶]
    • Efidac®[¶]
    • Myfedrine®[¶]
    • Pseudocot®[¶]
    • Ridafed®[¶]
    • Silfedrine®
    • Sudafed 12/24 Hour®
    • Sudafed Congestion®
    • Sudodrin®[¶]
    • SudoGest®
    • Sudrine®[¶]
    • Superfed®[¶]
    • Suphedrin®
    • AccuHist DM® (as a combination product containing Brompheniramine, Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Advil Allergy Sinus® (as a combination product containing Chlorpheniramine, Ibuprofen, Pseudoephedrine)
    • Advil Cold and Sinus® (as a combination product containing Ibuprofen, Pseudoephedrine)
    • Alavert Allergy and Sinus D-12® (as a combination product containing Loratadine, Pseudoephedrine)
    • Aldex GS® (as a combination product containing Guaifenesin, Pseudoephedrine)
    • Aldex GS DM® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)
    • Aleve-D Sinus and Cold® (as a combination product containing Naproxen, Pseudoephedrine)
    • Allergy Relief D® (as a combination product containing Cetirizine, Pseudoephedrine)
    • Ambifed® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Ambifed DM® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Biodec DM® (as a combination product containing Dextromethorphan, Pseudoephedrine)[§]
    • BP 8® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Brofed® (as a combination product containing Brompheniramine, Pseudoephedrine)[§]
    • Bromdex® (as a combination product containing Brompheniramine, Dextromethorphan, Pseudoephedrine)[§]
    • Bromfed® (as a combination product containing Brompheniramine, Pseudoephedrine)[§]
    • Bromfed DM® (as a combination product containing Brompheniramine, Dextromethorphan, Pseudoephedrine)
    • Bromhist DM® (as a combination product containing Brompheniramine, Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Bromphenex DM® (as a combination product containing Brompheniramine, Dextromethorphan, Pseudoephedrine)
    • Bromuphed® (as a combination product containing Brompheniramine, Pseudoephedrine)[§]
    • Bromuphed PD® (as a combination product containing Brompheniramine, Pseudoephedrine)[§]
    • Brotapp® (as a combination product containing Brompheniramine, Pseudoephedrine)
    • Brotapp-DM Cold and Cough® (as a combination product containing Brompheniramine, Dextromethorphan, Pseudoephedrine)
    • Brovex PSB® (as a combination product containing Brompheniramine, Pseudoephedrine)
    • Brovex PSB DM® (as a combination product containing Brompheniramine, Dextromethorphan, Pseudoephedrine)
    • Brovex SR® (as a combination product containing Brompheniramine, Pseudoephedrine)[§]
    • Carbofed DM® (as a combination product containing Brompheniramine, Dextromethorphan, Pseudoephedrine)[§]
    • Certuss-D® (as a combination product containing Chlophedianol, Guaifenesin, Pseudoephedrine)
    • Cetiri-D® (as a combination product containing Cetirizine, Pseudoephedrine)
    • Children's Advil Cold® (as a combination product containing Ibuprofen, Pseudoephedrine)
    • Children's Motrin Cold® (as a combination product containing Ibuprofen, Pseudoephedrine)
    • Chlorfed A SR® (as a combination product containing Chlorpheniramine, Pseudoephedrine)[§]
    • Clarinex-D® (as a combination product containing Desloratadine, Pseudoephedrine)
    • Claritin-D® (as a combination product containing Loratadine, Pseudoephedrine)
    • Coldamine® (as a combination product containing Chlorpheniramine, Methscopolamine, Pseudoephedrine)[§]
    • Coldmist DM® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Coldmist LA® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Colfed A® (as a combination product containing Chlorpheniramine, Pseudoephedrine)[§]
    • Corzall® (as a combination product containing Carbetapentane, Pseudoephedrine)[§]
    • Dallergy PSE® (as a combination product containing Chlorpheniramine, Methscopolamine, Pseudoephedrine)[§]
    • Deconamine® (as a combination product containing Chlorpheniramine, Pseudoephedrine)[§]
    • Deconomed SR® (as a combination product containing Chlorpheniramine, Pseudoephedrine)[§]
    • Defen LA® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Dimetane DX® (as a combination product containing Brompheniramine, Dextromethorphan, Pseudoephedrine)
    • Drixoral® (as a combination product containing Dexbrompheniramine, Pseudoephedrine)
    • Drymax® (as a combination product containing Chlorpheniramine, Methscopolamine, Pseudoephedrine)[§]
    • Dynahist ER® (as a combination product containing Chlorpheniramine, Pseudoephedrine)[§]
    • EndaCof-DC® (as a combination product containing Codeine, Pseudoephedrine)
    • EndaCof-PD® (as a combination product containing Brompheniramine, Dextromethorphan, Pseudoephedrine)[§]
    • Entex PSE® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Exall D® (as a combination product containing Carbetapentane, Guaifenesin, Pseudoephedrine)[§]
    • ExeFen DMX® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)
    • ExeFen IR® (as a combination product containing Guaifenesin, Pseudoephedrine)
    • Guaidex TR® (as a combination product containing Chlorpheniramine, Dextromethorphan, Guaifenesin, Methscopolamine, Pseudoephedrine)[§]
    • Hexafed® (as a combination product containing Dexchlorpheniramine, Pseudoephedrine)[§]
    • Histacol DM® (as a combination product containing Brompheniramine, Guaifenesin, Dexchlorpheniramine, Pseudoephedrine)[§]
    • Histex® (as a combination product containing Chlorpheniramine, Pseudoephedrine)[§]
    • Lodrane® (as a combination product containing Brompheniramine, Pseudoephedrine)[§]
    • LoHist-D® (as a combination product containing Chlorpheniramine, Pseudoephedrine)[§]
    • LoHist-PD® (as a combination product containing Brompheniramine, Pseudoephedrine)[§]
    • LoHist-PSB® (as a combination product containing Brompheniramine, Pseudoephedrine)
    • LoHist-PSB-DM® (as a combination product containing Brompheniramine, Dextromethorphan, Pseudoephedrine)
    • Lortuss DM® (as a combination product containing Dextromethorphan, Doxylamine, Pseudoephedrine)
    • Lortuss EX® (as a combination product containing Codeine, Guaifenesin, Pseudoephedrine)
    • Lortuss LQ® (as a combination product containing Doxylamine, Pseudoephedrine)
    • Medent DM® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Medent LD® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Mintex® (as a combination product containing Chlorpheniramine, Pseudoephedrine)[§]
    • Mucinex D® (as a combination product containing Guaifenesin, Pseudoephedrine)
    • Myphetane Dx® (as a combination product containing Brompheniramine, Dextromethorphan, Pseudoephedrine)[§]
    • Nalex® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Nasatab LA® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Neutrahist® (as a combination product containing Chlorpheniramine, Pseudoephedrine)[§]
    • Notuss-NXD® (as a combination product containing Chlorcyclizine, Codeine, Pseudoephedrine)[§]
    • Pediahist DM® (as a combination product containing Brompheniramine, Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Polyvent® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Pseudodine® (as a combination product containing Pseudoephedrine, Triprolidine)
    • Relcof PSE® (as a combination product containing Chlorpheniramine, Methscopolamine, Pseudoephedrine)[§]
    • Respa 1st® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Respaire® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Respivent D® (as a combination product containing Chlorpheniramine, Methscopolamine, Pseudoephedrine)[§]
    • Rezira® (as a combination product containing Hydrocodone, Pseudoephedrine)
    • Rondamine DM® (as a combination product containing Dextromethorphan, Pseudoephedrine)[§]
    • Rondec® (as a combination product containing Brompheniramine, Pseudoephedrine)[§]
    • Rondec DM® (as a combination product containing Dextromethorphan, Pseudoephedrine)[§]
    • Ru-Tuss DM® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Semprex-D® (as a combination product containing Acrivastine, Pseudoephedrine)
    • Suclor® (as a combination product containing Chlorpheniramine, Pseudoephedrine)[§]
    • Sudafed 12 Hour Pressure/Pain® (as a combination product containing Naproxen, Pseudoephedrine)
    • Sudafed Triple Action® (as a combination product containing Acetaminophen, Guaifenesin, Pseudoephedrine)
    • Sudahist® (as a combination product containing Chlorpheniramine, Pseudoephedrine)[§]
    • Sudatex DM® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Sudatrate® (as a combination product containing Methscopolamine, Pseudoephedrine)[§]
    • Tekral® (as a combination product containing Diphenhydramine, Pseudoephedrine)[§]
    • Tenar DM® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Tenar PSE® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Theraflu Max-D Severe Cold and Flu® (as a combination product containing Acetaminophen, Dextromethorphan, Guaifenesin, Pseudoephedrine)
    • Touro CC® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Touro LA® (as a combination product containing Guaifenesin, Pseudoephedrine)[§]
    • Triacin® (as a combination product containing Pseudoephedrine, Triprolidine)
    • Trikof D® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Trispec PSE® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Tussafed LA® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Tylenol Sinus Severe Congestion Daytime® (as a combination product containing Acetaminophen, Guaifenesin, Pseudoephedrine)
    • Vanacof® (as a combination product containing Chlophedianol, Dexchlorpheniramine, Pseudoephedrine)
    • Vanacof DX® (as a combination product containing Chlophedianol, Guaifenesin, Pseudoephedrine)
    • Viravan P® (as a combination product containing Pseudoephedrine, Pyrilamine)[§]
    • Viravan PDM® (as a combination product containing Dextromethorphan, Pseudoephedrine, Pyrilamine)[§]
    • Z-Cof DM® (as a combination product containing Dextromethorphan, Guaifenesin, Pseudoephedrine)[§]
    • Zodryl DEC® (as a combination product containing Codeine, Guaifenesin, Pseudoephedrine)
    • Zutripro® (as a combination product containing Chlorpheniramine, Hydrocodone, Pseudoephedrine)
    • Zymine DRX® (as a combination product containing Pseudoephedrine, Triprolidine)[§]
    • Zyrtec-D® (as a combination product containing Cetirizine, Pseudoephedrine)
    • Also available generically
    § These products are not currently approved by the FDA for safety, effectiveness, and quality. Federal law generally requires that prescription drugs in the U.S. be shown to be both safe and effective prior to marketing. Please see the FDA website for more information on unapproved drugs ( http://www.fda.gov/AboutFDA/Transparency/Basics/ucm213030.htm) and the approval process ( http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm).
    These branded products are no longer on the market and only generic alternatives are available.

    Oxycodone

    (ox i koe' done)

    IMPORTANT WARNING:

    Oxycodone extended-release (long-acting) tablets should be used only to treat people who need regularly scheduled doses of pain medication to treat continuous pain for an extended period of time. Extended-release oxycodone tablets should not be taken as-needed or to treat occasional episodes of pain.
    Oxycodone 60-mg tablets and oxycodone 160-mg tablets (not available in the United States) should only be used to treat people who are tolerant (used to the effects of a medication) to narcotic pain medication. These tablet strengths may cause serious breathing problems or death in people who are not tolerant to narcotics.
    Swallow oxycodone extended-release tablets whole; do not chew, break, divide, crush, or dissolve them. If you swallow broken, chewed, or crushed extended-release tablets, you will receive the entire dose of oxycodone at once, instead of slowly over 12 hours. This may cause serious problems, including overdose and death.
    Talk to your doctor about the risks of taking oxycodone.

    WHY is this medicine prescribed?

    Oxycodone is used to relieve moderate to severe pain. Oxycodone is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.
    Oxycodone is also available in combination with acetaminophen (Endocet, Percocet, Roxicet, Tylox, others); aspirin (Endodan, Percodan, Roxiprin, others); and ibuprofen (Combunox). This monograph only includes information about the use of oxycodone alone. If you are taking an oxycodone combination product, be sure to read information about all the ingredients in the product you are taking and ask your doctor or pharmacist for more information.

    HOW should this medicine be used?

    Oxycodone comes as a solution (liquid), concentrate solution, tablet, capsule, and extended-release (long-acting) tablet to take by mouth. The solution, concentrated solution, tablet, and capsule are usually taken with or without food every 4 to 6 hours, either as needed for pain or as regularly scheduled medications. The extended-release tablet are usually taken every 12 hours. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take oxycodone exactly as directed.
    If you are taking the oxycodone concentrate solution, be sure to carefully measure and double check the dose before taking the medication. Use the measuring dropper that comes with the medication to measure your dose. Mix the medication with at least 1 ounce (30 milliliters) of juice or other liquid, or with a semi-solid food such as applesauce or pudding. If you are taking oxycodone concentrate solution from an ampoule (small pre-packaged tube containing oxycodone liquid), be sure to follow your doctor's instructions for taking a dose. Ask your pharmacist or doctor if you have any questions about measuring your dose or taking your medication.
    Your doctor will likely start you on a low dose of oxycodone and may increase this dose over time if your pain is not controlled. After you take oxycodone for a period of time, your body may become used to the medication. If this happens, your doctor may need to increase your dose to control your pain. Talk to your doctor about how you are feeling during your treatment with oxycodone.
    Oxycodone can be habit-forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor. If you have been taking oxycodone for more than a few days, do not stop taking oxycodone suddenly. If you stop taking this medication suddenly, you may experience withdrawal symptoms such as restlessness, watery eyes, runny nose, sneezing, yawning, sweating, chills, muscle or joint aches or pains, weakness, irritability, anxiety, depression, difficulty falling asleep or staying asleep, cramps, nausea, vomiting, diarrhea, loss of appetite, fast heartbeat, and fast breathing. Your doctor will probably decrease your dose gradually. Call your doctor if you have any withdrawal symptoms when your dose is decreased or when you stop taking oxycodone.
    Ask your doctor or pharmacist for a copy of the manufacturer's information for the patient.

    Are there OTHER USES for this medicine?

    This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking oxycodone,
    • tell your doctor and pharmacist if you are allergic to oxycodone, codeine (in many pain relievers and cough medications), hydrocodone (in Hycodan, in Lortab, in Vicoprofen, others),dihydrocodeine (in Synalgos-DC, others), any other medications, or any of the ingredients in oxycodone liquid, tablets, or capsules. Ask your pharmacist for a list of the ingredients.
    • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants; antihistamines; buprenorphine (Buprenex, Subutex, in Suboxone); butorphanol (Stadol); medications for mental illness, nausea, or seizures; other medications for pain, especially narcotics; muscle relaxants; nalbuphine (Nubain); naloxone (Narcan); nalmefene (Revex); pentazocine (Talwin); sedatives;sleeping pills, or tranquilizers; Also tell your doctor or pharmacist if you are taking the following medications or if you have stopped taking them within the past two weeks: isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
    • tell your doctor if you have or have ever had asthma, lung disease, slowed breathing, or paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to take oxycodone.
    • tell your doctor if you drink or have ever drunk large amounts of alcohol and if you use or have ever used street drugs, or if you have overused prescription medications. Also tell your doctor if you have or have ever had a head injury,a tumor in your brain or nervous system, any condition causing increased pressure in your brain; hypothyroidism (condition in which the thyroid gland produces less hormone than normal), hallucinations (seeing things or hearing voices that do not exist); delirium tremens (severe withdrawal symptoms that may occur in people who drank large amounts of alcohol over time and have stopped drinking); kyphoscoliosis (curving of the spine that may cause breathing problems) low blood pressure;Addison's disease (condition in which the adrenal gland does not produce enough hormone), seizures; urethral stricture (blockage of the tube that allows urine to leave the body), enlarged prostate (a male reproductive gland), or heart, kidney,liver, or pancreas, or biliary tract disease.
    • tell your doctor if you are pregnant or plan to become pregnant, or are breast-feeding. If you become pregnant while taking oxycodone, call your doctor.
    • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking oxycodone.
    • you should know that this medication may make you drowsy. Do not drive a car, operate heavy machinery, or participate in any other possibly dangerous activities until you know how this medication affects you.
    • ask your doctor about the safe use of alcoholic beverages while you are taking oxycodone. When alcohol is taken with this medication, dangerous side effects can occur.
    • you should know that oxycodone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To help avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

    What SPECIAL DIETARY instructions should I follow?

    Unless your doctor tells you otherwise, continue your normal diet.

    What should I do IF I FORGET to take a dose?

    If you are taking oxycodone on a regular schedule, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

    What SIDE EFFECTS can this medicine cause?

    Oxycodone may cause side effects. Tell your doctor if any of these symptoms, are severe or do not go away:
    • nausea
    • vomiting
    • loss of appetite
    • constipation
    • dry mouth
    • lightheadedness
    • drowsiness
    • flushing
    • sweating
    • itching
    • weakness
    • headache
    • mood changes
    • decrease in pupil (dark circle in eye) size
    • red eyes
    Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
    • fast or slow heartbeat
    • difficulty breathing
    • slowed breathing
    • hives
    • rash
    • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
    • hoarseness
    • difficulty swallowing
    • hallucinating (seeing things or hearing voices that do not exist)
    • seizures
    • confusion
    • fainting
    • dizziness
    • loss of consciousness
    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].
    Oxycodone may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light and excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Throw away oxycodone concentrate solution 90 days after you open the product. Talk to your pharmacist about the proper disposal of your medication.
    Keep oxycodone in a safe place so that no one else can take it accidentally or on purpose. Keep track of how much liquid or how many tablets or capsules are left so you will know if any medication is missing.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
    Symptoms of overdose may include:
    • difficulty breathing or slowed or stopped breathing
    • excessive sleepiness
    • dizziness
    • fainting
    • limp or weak muscles
    • increase or decrease in pupil (dark circle in the eye) size
    • cold, clammy skin
    • slow or stopped heartbeat
    • blue color of skin, fingernails, lips, or area around the mouth
    • loss of consciousness or coma

    What OTHER INFORMATION should I know?

    If you are taking the extended-release tablets, you may notice something that looks like a tablet in your stool. This is just the empty tablet shell, and this does not mean that you did not get your complete dose of medication.
    Keep all appointments with your doctor.
    Do not let anyone else take your medication. Selling or giving away this medication may cause severe harm or death to others and is illegal.
    This prescription is not refillable. If you continue to experience pain after you finish the oxycodone, call your doctor.
    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    Brand Names

    • Dazidox®[¶]
    • Endocodone®[¶]
    • ETH-Oxydose®[¶]
    • Oxycontin®
    • Oxyfast®[¶]
    • OxyIR®[¶]
    • Percolone®[¶]
    • Roxicodone®
    • Combunox® (as a combination product containing Ibuprofen, Oxycodone)
    • Endocet® (as a combination product containing Acetaminophen, Oxycodone)
    • Endodan® (as a combination product containing Aspirin, Oxycodone)
    • Lynox® (as a combination product containing Acetaminophen, Oxycodone)[¶]
    • Magnacet® (as a combination product containing Acetaminophen, Oxycodone)
    • Narvox® (as a combination product containing Acetaminophen, Oxycodone)[¶]
    • Oxecta® (as a combination product containing Acetaminophen, Oxycodone)
    • Percocet® (as a combination product containing Acetaminophen, Oxycodone)
    • Percodan® (as a combination product containing Aspirin, Oxycodone)
    • Perloxx® (as a combination product containing Acetaminophen, Oxycodone)[¶]
    • Primlev® (as a combination product containing Acetaminophen, Oxycodone)
    • Roxicet® (as a combination product containing Acetaminophen, Oxycodone)
    • Roxiprin® (as a combination product containing Aspirin, Oxycodone)[¶]
    • Taxadone® (as a combination product containing Acetaminophen, Oxycodone)[¶]
    • Tylox® (as a combination product containing Acetaminophen, Oxycodone)
    • Xolox® (as a combination product containing Acetaminophen, Oxycodone)
    • Also available generically
    These branded products are no longer on the market and only generic alternatives are available.

    Tramadol

    (tra' ma dole)

    WHY is this medicine prescribed?

    Tramadol is used to relieve moderate to moderately severe pain. Tramadol extended-release tablets are only used by people who are expected to need medication to relieve pain around-the-clock for a long time. Tramadol is in a class of medications called opiate agonists. It works by changing the way the body senses pain.

    HOW should this medicine be used?

    Tramadol comes as a tablet and an extended-release (long-acting) tablet to take by mouth. The regular tablet is usually taken with or without food every 4-6 hours as needed. The extended-release tablet should be taken once a day. Take the extended-release tablet at about the same time of day every day, and either always take it with food or always take it without food. Take tramadol exactly as directed. Do not take more medication as a single dose or take more doses per day than prescribed by your doctor. Taking more tramadol than prescribed by your doctor may cause serious side effects or death.
    Your doctor may start you on a low dose of tramadol and gradually increase the amount of medication you take, not more often than every 3 days if you are taking the regular tablets or every 5 days if you are taking the extended-release tablets.
    Swallow the extended-release tablets whole; do not split, chew, or crush them. Do not snort (inhale powder from crushed tablet) or inject the dissolved extended-release tablets. Taking this medication in a way that is not recommended may cause serious side effects or death.
    Tramadol can be habit-forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor. Call your doctor if you find that you want to take extra medication or if you notice any other unusual changes in your behavior or mood.
    Do not stop taking tramadol without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking tramadol you may experience withdrawal symptoms such as nervousness; panic; sweating; difficulty falling asleep or staying asleep; runny nose, sneezing, or cough; numbness, pain, burning, or tingling in your hands or feet; hair standing on end; chills; nausea; uncontrollable shaking of a part of your body; diarrhea; or rarely, hallucinations (seeing things or hearing voices that do not exist).

    Are there OTHER USES for this medicine?

    This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking tramadol,
    • tell your doctor and pharmacist if you are allergic to tramadol or other opiate pain or cough medications such as meperidine (Demerol), morphine (Avinza, Kadian, MS Contin), codeine (in some pain medications and cough syrups), hydrocodone (in Vicodin), hydromorphone (Dilaudid), oxycodone (OxyContin, in Percocet), propoxyphene (Darvon, Darvon N, in Darvocet), any other medications, or any of the ingredients in tramadol tablets or extended-release tablets. Ask your pharmacist for a list of ingredients in tramadol tablets or extended release tablets.
    • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention any of the following: antifungal medications such as ketoconazole (Nizoral); digoxin (Lanoxin); erythromycin (E.E.S., E-Mycin, Erythrocin); monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate); medications for anxiety, mental illness, nausea, and pain; medications for seizures, such as carbamazepine (Tegretol); muscle relaxants such as cyclobenzaprine (Flexeril); promethazine (Phenergan); quinidine; rifampin (Rifadin, Rifamate, Rimactane, others); sedatives; sleeping pills; selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); tranquilizers; tricyclic antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil);and warfarin (Coumadin). Many other medications may also interact with tramadol, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
    • tell your doctor what herbal products you are taking, especially St. John's wort.
    • tell your doctor if you have or have ever had seizures; an infection in your brain or spine; a head injury, a brain tumor, a stroke, or any other condition that caused high pressure inside your skull; depression or thoughts about harming or killing yourself or planning or trying to do so; diabetes; breathing problems or lung disease; or kidney or liver disease. Also tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications.
    • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking tramadol, call your doctor.
    • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tramadol.
    • you should know that this medication may make you drowsy and may affect your coordination. Do not drive a car or operate machinery until you know how this medication affects you.
    • talk to your doctor about the safe use of alcohol while you are taking this medication. Alcohol can make the side effects from tramadol worse.
    • you should know that tramadol may cause dizziness, lightheadedness, and fainting when you get up from a lying position. To avoid this, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

    What SPECIAL DIETARY instructions should I follow?

    Talk to your doctor about drinking grapefruit juice while you are taking this medication.

    What should I do IF I FORGET to take a dose?

    If your doctor has told you to take tramadol regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

    What SIDE EFFECTS can this medicine cause?

    Tramadol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
    • dizziness
    • weakness
    • sleepiness
    • difficulty falling asleep or staying asleep
    • headache
    • nervousness
    • agitation
    • uncontrollable shaking of a part of the body
    • muscle tightness
    • changes in mood
    • drowsiness
    • heartburn or indigestion
    • nausea
    • vomiting
    • diarrhea
    • constipation
    • itching
    • sweating
    • chills
    • dry mouth
    Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section , call your doctor immediately:
    • seizures
    • sores on the inside of your mouth, nose, eyes, or throat
    • flu-like symptoms
    • hives
    • rash
    • difficulty swallowing or breathing
    • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
    • hoarseness
    • hallucinations (seeing things or hearing voices that do not exist)
    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].
    Tramadol may cause other side effects. Tell your doctor if you have any unusual problems while you are taking this medication.

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
    Symptoms of overdose may include:
    • decreased size of the pupil (the black circle in the center of the eye)
    • difficulty breathing
    • extreme drowsiness
    • unconsciousness
    • coma
    • seizure
    • heart attack

    What OTHER INFORMATION should I know?

    Keep all appointments with your doctor.
    Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    Brand Names

    • Conzip®
    • Ryzolt®
    • Ultram®
    • Ultram® ER
    • Ultracet® (as a combination product containing Acetaminophen, Tramadol)
    • Also available generically
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