• 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)

    Acetaminophen

    (a set a mee' noe fen)

    IMPORTANT WARNING:

    Infants' Acetaminophen Product Changes
    Children's acetaminophen has been available as concentrated infant drops (containing 80 mg of acetaminophen per 0.8 mL of drops or 80 mg of acetaminophen per 1 mL of drops) and as a less concentrated liquid (containing 160 mg acetaminophen per 5 mL of liquid) for older children. The Food and Drug Administration (FDA) received reports of children who were given too much acetaminophen when their caregivers mistakenly used a more concentrated product in place of a less concentrated product. To prevent this type of mistake, the concentrated infant drops will no longer be manufactured for sale in the U.S. Instead, all liquid acetaminophen products for children under 12 years of age will contain 160 mg of acetaminophen in 5 mL of medication.
    Although the more concentrated products are no longer being manufactured, they may still be available in stores for some time, and you may already have these products in your home. You may continue to buy and to give your child the concentrated products, but you will need to be especially careful to follow directions so that you give your child the right amount of medication.
    Before you give your child acetaminophen, check the active ingredient section in the Drug Facts label on the package to see whether the medication is an older concentrated product containing 80 mg per 0.8 mL or a newer product containing 160 mg per 5 mL. Do not assume that a product with the word "new" on the package contains the new concentration because the word "new" may also appear on older products. Read the directions on each product label carefully and give only the amount of medication listed in the instructions on that package to your child. Do not just give your child the same amount of medication that you have given in the past, follow instructions that you have read on a different package in the past, or rely on dosing instructions from the Internet, old dosing charts, or family members. If your child's doctor prescribes acetaminophen for your child, be sure that he or she knows which product you will be using so that he or she can prescribe the correct dose.
    If you have an older concentrated product, it will probably come with a dropper, and if you have a newer product, it may come with an oral syringe. Only measure your child's medication with the device included in that package . Do not switch measuring devices between the old and new acetaminophen liquid products.
    Talk to your pharmacist or doctor if you have questions about these acetaminophen product changes.

    IMPORTANT WARNING:

    Taking too much acetaminophen can cause liver damage, sometimes serious enough to require liver transplantation or cause death. You might accidentally take too much acetaminophen if you do not follow the directions on the prescription or package label carefully, or if you take more than one product that contains acetaminophen.
    To be sure that you take acetaminophen safely, you should:
    • not take more than one product that contains acetaminophen at a time. Read the labels of all the prescription and nonprescription medications you are taking to see if they contain acetaminophen. Be aware that abbreviations such as APAP, AC, Acetaminophn, Acetaminoph, Acetaminop, Acetamin, or Acetam. may be written on the label in place of the word acetaminophen. Ask your doctor or pharmacist if you don't know if a medication that you are taking contains acetaminophen.
    • take acetaminophen exactly as directed on the prescription or package label. Do not take more acetaminophen or take it more often than directed, even if you still have fever or pain. Ask your doctor or pharmacist if you do not know how much medication to take or how often to take your medication. Call your doctor if you still have pain or fever after taking your medication as directed.
    • be aware that you should not take more than 4000 mg of acetaminophen per day. If you need to take more than one product that contains acetaminophen, it may be difficult for you to calculate the total amount of acetaminophen you are taking. Ask your doctor or pharmacist to help you.
    • tell your doctor if you have or have ever had liver disease.
    • tell your doctor if you drink 3 or more alcoholic drinks every day. Talk to your doctor about the safe use of alcohol while you are taking acetaminophen.
    • stop taking your medication and call your doctor right away if you think you have taken too much acetaminophen, even if you feel well.
    Talk to your pharmacist or doctor if you have questions about the safe use of acetaminophen or acetaminophen-containing products.

    WHY is this medicine prescribed?

    Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

    HOW should this medicine be used?

    Acetaminophen comes as a tablet, chewable tablet, capsule, suspension or solution (liquid), drops (concentrated liquid; removed from U.S. market), extended-release (long-acting) tablet, and orally disintegrating tablet (tablet that dissolves quickly in the mouth), to take by mouth, with or without food. Acetaminophen also comes as a suppository to use rectally. Acetaminophen is available without a prescription, but your doctor may prescribe acetaminophen to treat certain conditions. Follow the directions on the package or prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
    If you are giving acetaminophen to your child, read the package label carefully to make sure that it is the right product for the age of the child. Do not give children acetaminophen products that are made for adults. Some products for adults and older children may contain too much acetaminophen for a younger child. Check the package label to find out how much medication the child needs. If you know how much your child weighs, give the dose that matches that weight on the chart. If you don't know your child's weight, give the dose that matches your child's age. Ask your child's doctor if you don't know how much medication to give your child.
    Acetaminophen comes in combination with other medications to treat cough and cold symptoms. 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.
    Swallow the extended-release tablets whole; do not split, chew, crush, or dissolve them.
    Place the orally disintegrating tablet ('Meltaways') in your mouth and allow to dissolve or chew it before swallowing.
    Shake the suspension well before each use to mix the medication evenly. Always use the measuring cup or syringe provided by the manufacturer to measure each dose of the solution or suspension. Do not switch dosing devices between different products; always use the device that comes in the product packaging.
    To insert an acetaminophen 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. (A left-handed person should lie on the right side and raise the 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. Stand up after about 15 minutes. Wash your hands thoroughly and resume your normal activities.
    Stop taking acetaminophen and call your doctor if your symptoms get worse, you develop new or unexpected symptoms, including redness or swelling, your pain lasts for more than 10 days, or your fever gets worse or lasts more than 3 days. Also stop giving acetaminophen to your child and call your child's doctor if your child develops new symptoms, including redness or swelling, or your child's pain lasts for longer than 5 days, or fever get worse or lasts longer than 3 days.
    Do not give acetaminophen to a child who has a sore throat that is severe or does not go away, or that occurs along with fever, headache, rash, nausea, or vomiting. Call the child's doctor right away, because these symptoms may be signs of a more serious condition.

    Are there OTHER USES for this medicine?

    Acetaminophen may also be used in combination with aspirin and caffeine to relieve the pain associated with migraine headache.
    This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking acetaminophen,
    • tell your doctor and pharmacist if you are allergic to acetaminophen, any other medications, or any of the ingredients in the product. Ask your pharmacist or check the label on the package for a list of ingredients.
    • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, or herbal products you are taking or plan to take. Be sure to mention anticoagulants ('blood thinners') such as warfarin (Coumadin); isoniazid (INH); certain medications for seizures including carbamazepine (Tegretol), phenobarbital, and phenytoin (Dilantin); medications for pain, fever, coughs, and colds; and phenothiazines (medications for mental illness and nausea). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
    • tell your doctor if you have any serious medical condition.
    • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking acetaminophen, call your doctor.
    • if you drink three or more alcoholic beverages every day, ask your doctor if you should take acetaminophen. Ask your doctor or pharmacist about the safe use of alcoholic beverages while taking acetaminophen.
    • you should know that combination acetaminophen products for cough and colds that contain nasal decongestants, antihistamines, cough suppressants, and expectorants should not be used in children younger than 2 years of age. Use of these medications in young children can cause serious and life-threatening effects or death. In children 2 through 11 years of age, combination cough and cold products should be used carefully and only according to the directions on the label.
    • if you have phenylketonuria (PKU, a inherited condition in which a special diet must be followed to prevent mental retardation), you should know that some brands of acetaminophen chewable tablets may be sweetened with aspartame. a source of phenylalanine.

    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 acetaminophen 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 may cause side effects.
    Some side effects can be serious. If you experience any of the following symptoms, stop taking acetaminophen and call your doctor immediately:
    • rash
    • hives
    • itching
    • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
    • hoarseness
    • difficulty breathing or swallowing
    Acetaminophen 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.
    If someone takes more than the recommended dose of acetaminophen, get medical help immediately, even if the person does not have any symptoms. Symptoms of overdose may include:
    • nausea
    • vomiting
    • loss of appetite
    • sweating
    • extreme tiredness
    • unusual bleeding or bruising
    • pain in the upper right part of the stomach
    • yellowing of the skin or eyes
    • flu-like symptoms

    What OTHER INFORMATION should I know?

    Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking acetaminophen.
    Ask your pharmacist any questions you have about acetaminophen.
    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

    • Acephen Rectal Suppository®
    • Feverall Rectal Suppository®
    • Mapap Rectal Suppository®
    • Neopap Supprettes Rectal Suppository®
    • Uniserts Rectal Suppository®
    • Aceta®[¶]
    • Actamin®
    • Adprin B®
    • Anacin®
    • Apacet®
    • Apara®
    • Apra®
    • Conacetol®
    • Dolono®
    • Feverall®
    • Genapap®
    • Genebs®
    • Gericet®
    • Halenol®
    • Infantaire®
    • Liquiprin®
    • Lopap®
    • Mapap®
    • Mardol®
    • Masophen®
    • Meda Cap®
    • Pain-Eze®
    • Panadol®
    • Panex®
    • Paramol®
    • Pediapap®
    • Q-Pap®
    • Redutemp®
    • Ridenol®
    • Silapap®
    • S-T Febrol®
    • Tactinal®
    • Tempra®
    • T-Panol®
    • Tycolene®
    • Tylenol®
    • Tylophen®
    • Uni-Ace®
    • Vitapap®
    • Aceta-Gesic® (as a combination product containing Acetaminophen, Phenyltoloxamine)[¶]
    • Actifed Plus® (as a combination product containing Acetaminophen, Pseudoephedrine, Triprolidine)
    • Acuflex® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • Ali Flex® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • Alka-Seltzer Plus Cold & Sinus® (as a combination product containing Acetaminophen, Phenylephrine)
    • Allay® (as a combination product containing Acetaminophen, Hydrocodone)[¶]
    • Alpain® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • Anabar® (as a combination product containing Acetaminophen, Phenyltoloxamine, Salicylamide)[§]
    • Anacin® (as a combination product containing Acetaminophen, Aspirin, Caffeine)
    • Anexsia® (as a combination product containing Acetaminophen, Hydrocodone)
    • Anolor DH5® (as a combination product containing Acetaminophen, Hydrocodone)
    • Apapgesic® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • Axocet® (as a combination product containing Acetaminophen, Butalbital)
    • Backprin® (as a combination product containing Acetaminophen, Caffeine, Magnesium Salicylate)
    • Bancap HC® (as a combination product containing Acetaminophen, Hydrocodone)
    • Bucet® (as a combination product containing Acetaminophen, Butalbital)[¶]
    • Butapap® (as a combination product containing Acetaminophen, Butalbital)
    • Butex Forte® (as a combination product containing Acetaminophen, Butalbital)
    • Cafgesic® (as a combination product containing Acetaminophen, Caffeine, Phenyltoloxamine, Salicylamide)[§]
    • Cephadyn® (as a combination product containing Acetaminophen, Butalbital)
    • Ceta Plus® (as a combination product containing Acetaminophen, Hydrocodone)
    • Cetazone T® (as a combination product containing Acetaminophen, Phenyltoloxamine, Salicylamide)[§]
    • Co-Apap® (as a combination product containing Acetaminophen, Chlorpheniramine, Dextromethorphan, Pseudoephedrine)
    • Codimal® (as a combination product containing Acetaminophen, Chlorpheniramine, Pseudoephedrine)
    • Co-Gesic® (as a combination product containing Acetaminophen, Hydrocodone)
    • Combiflex® (as a combination product containing Acetaminophen, Caffeine, Phenyltoloxamine, Salicylamide)[§]
    • Comtrex Cold and Cough® (as a combination product containing Acetaminophen, Dextromethorphan, Phenylephrine)
    • Contac Sinus® (as a combination product containing Acetaminophen, Pseudoephedrine)
    • Coricidin® (as a combination product containing Acetaminophen, Chlorpheniramine)
    • Dayquil® (as a combination product containing Acetaminophen, Dextromethorphan, Pseudoephedrine)
    • Dimetapp Cold And Fever® (as a combination product containing Acetaminophen, Brompheniramine, Pseudoephedrine)
    • Dolacet® (as a combination product containing Acetaminophen, Hydrocodone)
    • Dolagesic® (as a combination product containing Acetaminophen, Hydrocodone)
    • Dolgic® (as a combination product containing Acetaminophen, Butalbital)
    • Dologesic® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • Dolorex Forte® (as a combination product containing Acetaminophen, Hydrocodone)
    • Dristan Cold Non-Drowsy® (as a combination product containing Acetaminophen, Pseudoephedrine)
    • Drixoral Sinus® (as a combination product containing Acetaminophen, Dexbrompheniramine, Pseudoephedrine Extended Release Tablet)
    • Dryphen® (as a combination product containing Acetaminophen, Chlorpheniramine, Phenylephrine)
    • DuoCet® (as a combination product containing Acetaminophen, Hydrocodone)
    • Duogesic® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • Durabac® (as a combination product containing Acetaminophen, Caffeine, Phenyltoloxamine, Salicylamide)[§]
    • Durabac Forte® (as a combination product containing Acetaminophen, Caffeine, Magnesium Salicylate, Phenyltoloxamine)[§]
    • Duraflu® (as a combination product containing Acetaminophen, Dextromethorphan, Guaifenesin, Pseudoephedrine)
    • Duratuss A® (as a combination product containing Acetaminophen, Guaifenesin, Phenylephrine)
    • Emagrin Forte® (as a combination product containing Acetaminophen, Caffeine, Guaifenesin, Phenylephrine)
    • Endocet® (as a combination product containing Acetaminophen, Oxycodone)
    • Excedrin® (as a combination product containing Acetaminophen, Aspirin, Caffeine)
    • Excedrin Back & Body® (as a combination product containing Acetaminophen, Aspirin)
    • Excedrin PM® (as a combination product containing Acetaminophen, Diphenhydramine)
    • Flextra® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • Frenadol® (as a combination product containing Acetaminophen, Salicylamide)
    • Genace® (as a combination product containing Acetaminophen, Aspirin, Caffeine)
    • Genasec® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • Gendecon® (as a combination product containing Acetaminophen, Chlorpheniramine, Phenylephrine)
    • Goody's Extra Strength® (as a combination product containing Acetaminophen, Aspirin, Caffeine)
    • Goody's PM® (as a combination product containing Acetaminophen, Diphenhydramine)
    • Hycet® (as a combination product containing Acetaminophen, Hydrocodone)
    • Hycomed® (as a combination product containing Acetaminophen, Hydrocodone)
    • Hycomine Compound® (as a combination product containing Acetaminophen, Caffeine, Chlorpheniramine, Hydrocodone, Phenylephrine)
    • Hydrocet® (as a combination product containing Acetaminophen, Hydrocodone)
    • Hydrogesic® (as a combination product containing Acetaminophen, Hydrocodone)
    • Hyflex® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • Hy-Phen® (as a combination product containing Acetaminophen, Hydrocodone)
    • Kolephrin® (as a combination product containing Acetaminophen, Chlorpheniramine, Pseudoephedrine)
    • Levacet® (as a combination product containing Acetaminophen, Aspirin, Caffeine, Salicylamide)
    • Liquicet® (as a combination product containing Acetaminophen, Hydrocodone)
    • Lobac® (as a combination product containing Acetaminophen, Phenyltoloxamine, Salicylamide)[§]
    • Lorcet® (as a combination product containing Acetaminophen, Hydrocodone)
    • Lorsin® (as a combination product containing Acetaminophen, Chlorpheniramine, Pseudoephedrine)
    • Lortab® (as a combination product containing Acetaminophen, Hydrocodone)
    • Lurline PMS® (as a combination product containing Acetaminophen, Pamabrom, Vitamin B6)
    • Lynox® (as a combination product containing Acetaminophen, Oxycodone)
    • Magnacet® (as a combination product containing Acetaminophen, Oxycodone)
    • Major-gesic® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • Margesic-H® (as a combination product containing Acetaminophen, Hydrocodone)
    • Marten-Tab® (as a combination product containing Acetaminophen, Butalbital)
    • Masophen PM® (as a combination product containing Acetaminophen, Diphenhydramine)
    • Maxidone® (as a combination product containing Acetaminophen, Hydrocodone)
    • Maxiflu DM® (as a combination product containing Acetaminophen, Dextromethorphan, Guaifenesin, Pseudoephedrine)
    • Midol PMS® (as a combination product containing Acetaminophen, Pamabrom, Pyrilamine)
    • Migralam® (as a combination product containing Acetaminophen, Caffeine, Isometheptene)
    • MigraTen® (as a combination product containing Acetaminophen, Caffeine, Isometheptene)
    • Migrend® (as a combination product containing Acetaminophen, Caffeine, Isometheptene)
    • Narvox® (as a combination product containing Acetaminophen, Oxycodone)
    • Norco® (as a combination product containing Acetaminophen, Hydrocodone)
    • Novagesic® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • NyCair® (as a combination product containing Acetaminophen, Dextromethorphan, Doxylamine, Pseudoephedrine)
    • NyQuil Cold/Flu Relief® (as a combination product containing Acetaminophen, Dextromethorphan, Doxylamine)
    • Oncet® (as a combination product containing Acetaminophen, Hydrocodone)
    • Ornex® (as a combination product containing Acetaminophen, Pseudoephedrine)
    • Pamprin® (as a combination product containing Acetaminophen, Pamabrom, Pyrilamine)
    • Panacet® (as a combination product containing Acetaminophen, Hydrocodone)
    • Panlor® (as a combination product containing Acetaminophen, Hydrocodone)
    • Panritis Forte® (as a combination product containing Acetaminophen, Salicylamide)
    • Percocet® (as a combination product containing Acetaminophen, Oxycodone)
    • Percogesic® (as a combination product containing Acetaminophen, Phenyltoloxamine)[¶]
    • Perisine® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • Perloxx® (as a combination product containing Acetaminophen, Oxycodone)
    • Phenagesic® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • Phenapap® (as a combination product containing Acetaminophen, Pseudoephedrine)
    • Phenflu DM® (as a combination product containing Acetaminophen, Dextromethorphan, Guaifenesin, Phenylephrine)
    • Phenylgesic® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • Phlemgesic® (as a combination product containing Acetaminophen, Dextromethorphan, Guaifenesin, Pseudoephedrine)
    • Phrenilin® (as a combination product containing Acetaminophen, Butalbital)
    • Polygesic® (as a combination product containing Acetaminophen, Hydrocodone)
    • Premesyn PMS® (as a combination product containing Acetaminophen, Pamabrom, Pyrilamine)
    • Primlev® (as a combination product containing Acetaminophen, Oxycodone)
    • Procet® (as a combination product containing Acetaminophen, Hydrocodone)
    • Prodrin® (as a combination product containing Acetaminophen, Caffeine, Isometheptene)
    • Promacet® (as a combination product containing Acetaminophen, Butalbital)
    • Prominol® (as a combination product containing Acetaminophen, Butalbital)
    • Protid® (as a combination product containing Acetaminophen, Chlorpheniramine, Phenylephrine)
    • Q-Gesic® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • Relagesic® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • Repan CF® (as a combination product containing Acetaminophen, Butalbital)
    • Rhinoflex® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • Rhinogesic® (as a combination product containing Acetaminophen, Chlorpheniramine, Phenylephrine, Salicylamide)
    • Robitussin Cold Cough and Flu® (as a combination product containing Acetaminophen, Dextromethorphan, Guaifenesin, Pseudoephedrine)
    • Roxicet® (as a combination product containing Acetaminophen, Oxycodone)
    • Saleto® (as a combination product containing Acetaminophen, Aspirin, Caffeine, Salicylamide)
    • Sedapap® (as a combination product containing Acetaminophen, Butalbital)[¶]
    • Simplet® (as a combination product containing Acetaminophen, Chlorpheniramine, Pseudoephedrine)
    • Sinarest® (as a combination product containing Acetaminophen, Chlorpheniramine, Pseudoephedrine)
    • Sine-Aid® (as a combination product containing Acetaminophen, Pseudoephedrine)
    • Sine-Off Sinus and Cold® (as a combination product containing Acetaminophen, Chlorpheniramine, Phenylephrine)
    • Singlet® (as a combination product containing Acetaminophen, Chlorpheniramine, Pseudoephedrine)
    • Sinumed® (as a combination product containing Acetaminophen, Chlorpheniramine, Pseudoephedrine)
    • Sinus Aid® (as a combination product containing Acetaminophen, Pseudoephedrine)
    • Sinutab® (as a combination product containing Acetaminophen, Pseudoephedrine)
    • Sominex Pain Relief® (as a combination product containing Acetaminophen, Diphenhydramine)
    • Staflex® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • Stagesic® (as a combination product containing Acetaminophen, Hydrocodone)
    • Sudafed PE Cold & Cough® (as a combination product containing Acetaminophen, Dextromethorphan, Guaifenesin, Phenylephrine)
    • Sudafed PE Sinus Headache® (as a combination product containing Acetaminophen, Phenylephrine)
    • Sudogest® (as a combination product containing Acetaminophen, Pseudoephedrine)
    • Supac® (as a combination product containing Acetaminophen, Aspirin, Caffeine)
    • Suphedrin Sinus® (as a combination product containing Acetaminophen, Pseudoephedrine)
    • Talacen® (as a combination product containing Acetaminophen, Pentazocine)
    • Tavist Allergy/Sinus/Headache® (as a combination product containing Acetaminophen, Clemastine, Pseudoephedrine)
    • Tavist Sinus® (as a combination product containing Acetaminophen, Pseudoephedrine)
    • Taxadone® (as a combination product containing Acetaminophen, Oxycodone)
    • Tencon® (as a combination product containing Acetaminophen, Butalbital)
    • T-Gesic® (as a combination product containing Acetaminophen, Hydrocodone)
    • Theraflu Sore Throat® (as a combination product containing Acetaminophen, Chlorpheniramine, Pseudoephedrine)
    • Triaminic Cold And Fever® (as a combination product containing Acetaminophen, Chlorpheniramine, Dextromethorphan, Pseudoephedrine)
    • Triaprin® (as a combination product containing Acetaminophen, Butalbital)[¶]
    • Tricom® (as a combination product containing Acetaminophen, Chlorpheniramine, Pseudoephedrine)
    • Tylefon® (as a combination product containing Acetaminophen, Chlorzoxazone)
    • Tylenol Cold® (as a combination product containing Acetaminophen, Dextromethorphan, Pseudoephedrine)
    • Tylox® (as a combination product containing Acetaminophen, Oxycodone)
    • Ugesic® (as a combination product containing Acetaminophen, Hydrocodone)
    • Ultracet® (as a combination product containing Acetaminophen, Tramadol)
    • Uni-Case® (as a combination product containing Acetaminophen, Aspirin, Caffeine)
    • Uni-Perr® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • Unisom With Pain Relief® (as a combination product containing Acetaminophen, Diphenhydramine)
    • Valorin Extra® (as a combination product containing Acetaminophen, Caffeine)
    • Vanacet® (as a combination product containing Acetaminophen, Hydrocodone)
    • Vanquish® (as a combination product containing Acetaminophen, Aspirin, Caffeine)
    • Vendone® (as a combination product containing Acetaminophen, Hydrocodone)
    • Vicks 44 Cold, Flu and Cough® (as a combination product containing Acetaminophen, Chlorpheniramine, Dextromethorphan, Pseudoephedrine)
    • Vicodin® (as a combination product containing Acetaminophen, Hydrocodone)
    • Vidone® (as a combination product containing Acetaminophen, Hydrocodone)
    • Vistra® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • Vitoxapap® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • Xodol® (as a combination product containing Acetaminophen, Hydrocodone)
    • Xolox® (as a combination product containing Acetaminophen, Oxycodone)
    • Zamicet® (as a combination product containing Acetaminophen, Hydrocodone)
    • Zflex® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • Zgesic® (as a combination product containing Acetaminophen, Phenyltoloxamine)[§]
    • Zydone® (as a combination product containing Acetaminophen, Hydrocodone)
    • Also available generically

    Other Names

    • APAP
    • N-acetyl-para-aminophenol
    • Paracetamol
    § 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 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)
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