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Chlorpheniramine

pronounced as(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 medication 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.

Other uses for this medicine

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

What special precautions should I follow?

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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?

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

What should I do if I forget a dose?

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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 medication cause?

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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 storage conditions are needed for this medicine?

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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.

In case of emergency/overdose

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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?

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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

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  • Aller-Chlor®
  • Allerlief®
  • Chlorphen-12®
  • Chlor-Trimeton Allergy®
  • Pediatan®
  • Ridramin®
  • TanaHist PD®§
  • Teldrin HBP®

Brand names of combination products

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  • AccuHist® (containing Chlorpheniramine, Phenylephrine)
  • Actifed Cold and Allergy® (containing Chlorpheniramine, Phenylephrine)
  • Advil Allergy Sinus® (containing Chlorpheniramine, Ibuprofen, Pseudoephedrine)
  • Aerohist® (containing Chlorpheniramine, Methscopolamine)§
  • Aerohist Plus® (containing Chlorpheniramine, Methscopolamine, Phenylephrine)§
  • Aerokid® (containing Chlorpheniramine, Methscopolamine, Phenylephrine)
  • Ah Chew® (containing Chlorpheniramine, Phenylephrine)§
  • Ah Chew Ultra® (containing Chlorpheniramine, Phenylephrine, Methscopolamine)§
  • Alka-Seltzer Plus Cold and Cough Formula® (containing Aspirin, Chlorpheniramine, Dextromethorphan, Phenylephrine)
  • Alka-Seltzer Plus Fast Powder Packs® (containing Acetaminophen, Chlorpheniramine, Phenylephrine)
  • Alka-Seltzer Plus Flu Formula® (containing Acetaminophen, Chlorpheniramine, Dextromethorphan, Phenylephrine)
  • Alka-Seltzer Plus Sparkling Original Cold Formula® (containing Aspirin, Chlorpheniramine, Phenylephrine)
  • Allerest PE® (containing Chlorpheniramine, Phenylephrine)
  • Allergy DN II® (containing Chlorpheniramine, Methscopolamine)§
  • Allergy DN PE® (containing Chlorpheniramine, Methscopolamine, Phenylephrine)§
  • AllerTan® (containing Chlorpheniramine, Phenylephrine, Pyrilamine)
  • AlleRx® (containing Chlorpheniramine, Phenylephrine)§
  • Amerituss AD® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)
  • Atrohist® (containing Chlorpheniramine, Phenylephrine, Pyrilamine)
  • Atuss DM® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)
  • Atuss HD® (containing Chlorpheniramine, Hydrocodone, Phenylephrine)
  • Baltussin HC® (containing Chlorpheniramine, Hydrocodone, Phenylephrine)
  • Broncopectol® (containing Chlorpheniramine, Dextromethorphan, Guaifenesin, Phenylephrine)
  • Bronkids® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)§
  • Bronkotuss® (containing Chlorpheniramine, Ephedrine, Guaifenesin)
  • C Phen® (containing Chlorpheniramine, Phenylephrine)§
  • C Phen DM® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)§
  • Cardec DM® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)
  • Centergy® (containing Chlorpheniramine, Phenylephrine)§
  • Centergy DM® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)§
  • Ceron® (containing Chlorpheniramine, Phenylephrine)
  • Ceron DM® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)§
  • Cerose DM® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)
  • Children's Dimetapp Long Acting Cough Plus Cold® (containing Chlorpheniramine, Dextromethorphan)
  • Children's Dimetapp Multisymptom Cold and Flu® (containing Acetaminophen, Chlorpheniramine, Dextromethorphan, Phenylephrine)
  • Children's Robitussin Cough and Cold Long-Acting® (containing Chlorpheniramine, Dextromethorphan)
  • Chlordex GP® (containing Chlorpheniramine, Dextromethorphan, Guaifenesin, Phenylephrine)§
  • Chlorfed A SR® (containing Chlorpheniramine, Pseudoephedrine)§
  • Coldamine® (containing Chlorpheniramine, Methscopolamine, Pseudoephedrine)§
  • Colfed A® (containing Chlorpheniramine, Pseudoephedrine)§
  • Colrex® (containing Acetaminophen, Chlorpheniramine, Codeine, Phenylephrine)
  • Comhist® (containing Chlorpheniramine, Phenylephrine, phenyltoloxamine)
  • Comtrex Cold and Cough Day/Night® (containing Acetaminophen, Chlorpheniramine, Dextromethorphan, Phenylephrine)
  • Conal® (containing Chlorpheniramine, Phenylephrine, Pyrilamine)
  • Contac Cold and Flu Maximum Strength® (containing Acetaminophen, Chlorpheniramine, Phenylephrine)
  • Corfen DM® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)
  • Coricidin® (containing Acetaminophen, Chlorpheniramine)
  • Coricidin HBP Cold and Flu® (containing Acetaminophen, Chlorpheniramine)
  • Coricidin HBP Cough and Cold® (containing Chlorpheniramine, Dextromethorphan)
  • Coricidin HBP Day and Night Multi-Symptom Cold® (containing Acetaminophen, Chlorpheniramine, Dextromethorphan, Guaifenesin)
  • Coricidin HBP Maximum Strength Flu® (containing Acetaminophen, Chlorpheniramine, Dextromethorphan)
  • Dallergy Drops® (containing Chlorpheniramine, Phenylephrine)
  • Dallergy PE® (containing Chlorpheniramine, Methscopolamine, Phenylephrine)§
  • Dallergy PSE® (containing Chlorpheniramine, Methscopolamine, Pseudoephedrine)§
  • Deconamine® (containing Chlorpheniramine, Pseudoephedrine)§
  • Deconomed SR® (containing Chlorpheniramine, Pseudoephedrine)§
  • Dehistine® (containing Chlorpheniramine, Methscopolamine, Phenylephrine)§
  • Dexodryl® (containing Chlorpheniramine)§
  • Donatussin DM® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)
  • Dristan Cold Multi-Symptom Formula® (containing Acetaminophen, Chlorpheniramine, Phenylephrine)
  • Drymax® (containing Chlorpheniramine, Methscopolamine, Pseudoephedrine)§
  • Dynahist ER® (containing Chlorpheniramine, Pseudoephedrine)§
  • EndaCof-C® (containing Chlorpheniramine, Codeine)§
  • Endal CD® (containing Chlorpheniramine, Codeine, Phenylephrine)
  • Extendryl® (containing Chlorpheniramine, Methscopolamine, Phenylephrine)§
  • Guaidex TR® (containing Chlorpheniramine, Dextromethorphan, Guaifenesin, Methscopolamine, Pseudoephedrine)§
  • Histadec® (containing Chlorpheniramine, Phenylephrine)
  • Histex® (containing Chlorpheniramine, Pseudoephedrine)§
  • Histinex HC® (containing Chlorpheniramine, Hydrocodone, Phenylephrine)
  • Hycomine Compound® (containing Acetaminophen, Caffeine, Chlorpheniramine, Hydrocodone, Phenylephrine)
  • LoHist-D® (containing Chlorpheniramine, Pseudoephedrine)§
  • Maxichlor® (containing Chlorpheniramine, Dextromethorphan)
  • Maxiphen ADT® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)§
  • Mintex® (containing Chlorpheniramine, Pseudoephedrine)§
  • Mintuss DR® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)§
  • Nasohist® (containing Chlorpheniramine, Phenylephrine)
  • Nasohist DM® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)
  • Neo DM® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)§
  • Neutrahist® (containing Chlorpheniramine, Pseudoephedrine)§
  • NoHist® (containing Chlorpheniramine, Phenylephrine)§
  • NoHist-DM® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)
  • NoHist-LQ® (containing Chlorpheniramine, Phenylephrine)
  • Norel DM® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)§
  • Norel SR® (containing Acetaminophen, Chlorpheniramine, Phenylephrine, Phenyltoloxamine)§
  • Novahistine® (containing Chlorpheniramine, Phenylephrine)
  • Omnihist II LA® (containing Chlorpheniramine, Methscopolamine, Phenylephrine)§
  • PediaCare Children's Fever Reducer Plus Cough and Runny Nose® (containing Acetaminophen, Chlorpheniramine, Dextromethorphan)
  • PediaCare Children's Fever Reducer Plus Flu® (containing Acetaminophen, Chlorpheniramine, Dextromethorphan, Phenylephrine)
  • PediaCare Children's Fever Reducer Plus Multi-Symptom Cold® (containing Acetaminophen, Chlorpheniramine, Dextromethorphan, Phenylephrine)
  • Pediacof® (containing Chlorpheniramine, Codeine, Phenylephrine, Potassium Iodide)
  • Phenabid® (containing Chlorpheniramine, Phenylephrine)§
  • Poly Hist PD® (containing Chlorpheniramine, Phenylephrine, Pyrilamine)§
  • Poly-Tussin DM® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)
  • Protid® (containing Acetaminophen, Chlorpheniramine, Phenylephrine)
  • Pyrlex CB® (containing Chlorpheniramine, Pyrilamine)§
  • Quartuss® (containing Chlorpheniramine, Dextromethorphan, Guaifenesin, Phenylephrine)§
  • Quartuss DM® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)§
  • Re Allergy AM/PM® (containing Chlorpheniramine, Methscopolamine, Phenylephrine)§
  • Redur PCM® (containing Chlorpheniramine, Phenylephrine)§
  • Relcof CPM® (containing Chlorpheniramine, Methscopolamine)§
  • Relcof PE® (containing Chlorpheniramine, Methscopolamine, Phenylephrine)§
  • Relcof PSE® (containing Chlorpheniramine, Methscopolamine, Pseudoephedrine)§
  • RemeTussin DM® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)§
  • Rescon® (containing Chlorpheniramine, Methscopolamine, Phenylephrine)§
  • Respivent D® (containing Chlorpheniramine, Methscopolamine, Pseudoephedrine)§
  • Robitussin Cough and Cold Long-Acting® (containing Chlorpheniramine, Dextromethorphan)
  • Robitussin Night Time Cough, Cold, and Flu® (containing Acetaminophen, Chlorpheniramine, Dextromethorphan, Phenylephrine)
  • Rolatuss® (containing Ammonium Chloride, Chlorpheniramine, Codeine, Phenylephrine)
  • Rondex® (containing Chlorpheniramine, Phenylephrine)
  • R-Tanna® (containing Chlorpheniramine, Phenylephrine)§
  • Rynatan® (containing Chlorpheniramine, Phenylephrine)§
  • Rynatuss® (containing Carbetapentane, Chlorpheniramine, Ephedrine, Phenylephrine)§
  • Ryneze® (containing Chlorpheniramine, Methscopolamine)
  • Ryneze® (containing Chlorpheniramine, Methscopolamine)§
  • Ry-Tuss® (containing Carbetapentane, Chlorpheniramine, Ephedrine, Phenylephrine)§
  • ScopoHist® (containing Chlorpheniramine, Methscopolamine, Phenylephrine)§
  • Sildec PE DM® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)§
  • Sine-Off Cough/Cold® (containing Acetaminophen, Dextromethorphan, Guaifenesin, Phenylephrine)
  • Sine-Off Sinus/Cold® (containing Acetaminophen, Chlorpheniramine, Phenylephrine)
  • Sonahist® (containing Chlorpheniramine, Phenylephrine)§
  • Sonahist DM® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)§
  • Statuss DM® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)§
  • Suclor® (containing Chlorpheniramine, Pseudoephedrine)§
  • Sudafed PE Sinus/Allergy® (containing Chlorpheniramine, Phenylephrine)
  • Sudahist® (containing Chlorpheniramine, Pseudoephedrine)§
  • Sympak PDX® (containing Chlorpheniramine, Methscopolamine, Phenylephrine)§
  • Triall® (containing Chlorpheniramine, Methscopolamine, Phenylephrine)§
  • Triaminic Cold and Allergy® (containing Chlorpheniramine, Phenylephrine)
  • Triaminic Multi-Symptom Fever® (containing Acetaminophen, Chlorpheniramine, Dextromethorphan)
  • Trital DM® (containing Chlorpheniramine, Dextromethorphan, Phenylephrine)§
  • Tussionex® (containing Chlorpheniramine, Hydrocodone)
  • Tylenol Allergy Multi-Symptom® (containing Acetaminophen, Chlorpheniramine, Phenylephrine)
  • Tylenol Cold Multi-Symptom Nighttime® (containing Acetaminophen, Chlorpheniramine, Dextromethorphan, Phenylephrine)
  • Tylenol Sinus Congestion and Pain Nighttime® (containing Acetaminophen, Chlorpheniramine, Phenylephrine)
  • Vanex-HD® (containing Chlorpheniramine, Hydrocodone, Phenylephrine)
  • Vicks Children's NyQuil Cold and Flu® (containing Chlorpheniramine, Dextromethorphan)
  • Vicks Formula 44 Custom Care Cough and Cold PM® (containing Acetaminophen, Chlorpheniramine, Dextromethorphan)
  • VisRx® (containing Chlorpheniramine, Methscopolamine)§
  • Zodryl AC® (containing Chlorpheniramine, Codeine)
  • Zutripro® (containing Chlorpheniramine, Hydrocodone, Pseudoephedrine)

§ 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.

Last Revised - 07/08/2011

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