• 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.

    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.

    Ibuprofen

    (eye byoo' proe fen)

    IMPORTANT WARNING:

    People who take nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as ibuprofen may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke;if you smoke;and if you have or have ever had high cholesterol, high blood pressure, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech.
    If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not take ibuprofen right before or right after the surgery.
    NSAIDs such as ibuprofen may cause ulcers, bleeding, or holes in the stomach or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, or who drink three or more alcoholic drinks per day while taking ibuprofen. Tell your doctor if you take any of the following medications: anticoagulants ('blood thinners') such as warfarin (Coumadin); aspirin; other NSAIDs such as ketoprofen (Orudis KT, Actron) and naproxen (Aleve, Naprosyn); or oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone). Also tell your doctor if you have or have ever had ulcers, bleeding in your stomach or intestines, or other bleeding disorders. If you experience any of the following symptoms, stop taking ibuprofen and call your doctor: stomach pain, heartburn, vomit that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.
    Keep all appointments with your doctor and the laboratory. Your doctor will monitor your symptoms carefully and will probably order certain tests to check your body's response to ibuprofen. Be sure to tell your doctor how you are feeling so that your doctor can prescribe the right amount of medication to treat your condition with the lowest risk of serious side effects.
    Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with prescription ibuprofen and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.

    WHY is this medicine prescribed?

    Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve mild pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

    HOW should this medicine be used?

    Prescription ibuprofen comes as a tablet to take by mouth. It is usually taken three or four times a day for arthritis or every 4 to 6 hours as needed for pain. Nonprescription ibuprofen comes as a tablet, chewable tablet, suspension (liquid), and drops (concentrated liquid). Adults and children older than 12 years of age may usually take nonprescription ibuprofen every 4 to 6 hours as needed for pain or fever. Children and infants may usually be given nonprescription ibuprofen every 6 to 8 hours as needed for pain or fever, but should not be given more than 4 doses in 24 hours. Ibuprofen may be taken with food or milk to prevent stomach upset. If you are taking ibuprofen on a regular basis, you should take it at the same time(s) every day. 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 ibuprofen 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.
    Ibuprofen comes alone and in combination with other medications. Some of these combination products are available by prescription only, and some of these combination products are available without a prescription and are used to treat cough and cold symptoms and other conditions. If your doctor has prescribed a medication that contains ibuprofen, you should be careful not to take any nonprescription medications that also contain ibuprofen.
    If you are selecting a product to treat cough or cold symptoms, ask your doctor or pharmacist for advice on which product is best for you. Check nonprescription 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 ibuprofen, 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 ibuprofen or a combination product that contains ibuprofen 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 ibuprofen products that are made for adults to children.
    Before you give an ibuprofen 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.
    Shake the suspension and drops well before each use to mix the medication evenly. Use the measuring cup provided to measure each dose of the suspension, and use the dosing device provided to measure each dose of the drops.
    The chewable tablets may cause a burning feeling in the mouth or throat. Take the chewable tablets with food or water.
    Stop taking nonprescription ibuprofen and call your doctor if your symptoms get worse, you develop new or unexpected symptoms, the part of your body that was painful becomes red or swollen, your pain lasts for more than 10 days, or your fever lasts more than 3 days. Stop giving nonprescription ibuprofen to your child and call your child's doctor if your child does not start to feel better during the first 24 hours of treatment. Also stop giving nonprescription ibuprofen to your child and call your child's doctor if your child develops new symptoms, including redness or swelling on the painful part of his body, or if your child's pain or fever get worse or lasts longer than 3 days.
    Do not give nonprescription ibuprofen to a child who has a sore throat that is severe or does not go away, or that comes along with fever, headache, 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?

    Ibuprofen is also sometimes used to treat ankylosing spondylitis (arthritis that mainly affects the spine), gouty arthritis (joint pain caused by a build-up of certain substances in the joints), and psoriatic arthritis (arthritis that occurs with a long-lasting skin disease that causes scaling and swelling). Talk to your doctor about the risks of using this drug for your condition.
    This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking ibuprofen,
    • tell your doctor and pharmacist if you are allergic to ibuprofen, aspirin or other NSAIDs such as ketoprofen (Orudis KT, Actron) and naproxen (Aleve, Naprosyn), any other medications, or any of the inactive ingredients in the type of ibuprofen you plan to take. Ask your pharmacist or check the label on the package for a list of the inactive 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 the medications listed in the IMPORTANT WARNING section and any of the following: 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); diuretics ('water pills'); lithium (Eskalith, Lithobid); and methotrexate (Rheumatrex). Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
    • do not take nonprescription ibuprofen with any other medication for pain unless your doctor tells you that you should.
    • tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the inside of the nose); swelling of the hands, arms, feet, ankles, or lower legs; lupus (a condition in which the body attacks many of its own tissues and organs, often including the skin, joints, blood, and kidneys); or liver or kidney disease. If you are giving ibuprofen to a child, tell the child's doctor if the child has not been drinking fluids or has lost a large amount of fluid from repeated vomiting or diarrhea.
    • 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 ibuprofen, call your doctor.
    • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking ibuprofen.
    • if you have phenylketonuria (PKU, an inborn disease in which mental retardation develops if a specific diet is not followed), read the package label carefully before taking nonprescription ibuprofen. Some types of nonprescription ibuprofen 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?

    If you are taking ibuprofen on a regular basis, 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?

    Ibuprofen may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
    • constipation
    • diarrhea
    • gas or bloating
    • dizziness
    • nervousness
    • ringing in the ears
    Some side effects can be serious. If you experience any of the following symptoms, or those mentioned in the IMPORTANT WARNING section, call your doctor immediately. Do not take any more ibuprofen until you speak to your doctor.
    • unexplained weight gain
    • fever
    • blisters
    • rash
    • itching
    • hives
    • swelling of the eyes, face, throat, arms, hands, feet, ankles, or lower legs
    • difficulty breathing or swallowing
    • hoarseness
    • excessive tiredness
    • pain in the upper right part of the stomach
    • nausea
    • loss of appetite
    • yellowing of the skin or eyes
    • flu-like symptoms
    • pale skin
    • fast heartbeat
    • cloudy, discolored, or bloody urine
    • back pain
    • difficult or painful urination
    • blurred vision, changes in color vision, or other vision problems
    • red or painful eyes
    • stiff neck
    • headache
    • confusion
    • aggression
    Ibuprofen 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.

    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 overdosage may include:
    • dizziness
    • fast eye movements that you cannot control
    • slow breathing or short periods of time without breathing
    • blue color around the lips, mouth, and nose

    What OTHER INFORMATION should I know?

    If you are taking prescription ibuprofen, 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

    • Addaprin®
    • Advil®
    • Dolgesic®
    • Genpril®
    • Haltran®
    • IB Pro®
    • Ibifon 600®
    • Ibren®
    • Ibuprohm®
    • Menadol®
    • Midol® Cramps & Bodyaches
    • Motrin®
    • Nuprin®
    • Q-Profen®
    • Rufen®
    • Saleto-200®
    • Samson®
    • Tab-Profen®
    • Ultraprin®
    • Uni-Pro®
    • Wal-Profen®
    • Advil® Allergy Sinus (as a combination product containing Chlorpheniramine, Ibuprofen, Pseudoephedrine)
    • Advil® Cold and Sinus (as a combination product containing Ibuprofen, Pseudoephedrine)
    • Advil® PM (as a combination product containing Diphenhydramine, Ibuprofen)
    • Combunox® (as a combination product containing Ibuprofen, Oxycodone)
    • Dayquil® Pressure and Pain (as a combination product containing Ibuprofen, Pseudoephedrine)
    • Dimetapp® Sinus (as a combination product containing Ibuprofen, Pseudoephedrine)
    • Dristan® Sinus (as a combination product containing Ibuprofen, Pseudoephedrine)
    • Ibudone® (as a combination product containing Hydrocodone, Ibuprofen)
    • Motrin® PM (as a combination product containing Diphenhydramine, Ibuprofen)
    • Reprexain® (as a combination product containing Hydrocodone, Ibuprofen)
    • Sine-Aid IB® (as a combination product containing Ibuprofen, Pseudoephedrine)
    • Vicoprofen® (as a combination product containing Hydrocodone, Ibuprofen)
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