Brompheniramine, Phenylpropanolamine, and Codeine

The product is a bluish pink to pink syrup with a raspberry flavor. Each 5 mL (1 teaspoonful) contains:

Brompheniramine Maleate, USP ........................................2 mg

Phenylpropanolamine Hydrochloride, USP .........................12.5 mg

*Codeine Phosphate, USP .................................................10 mg

*(WARNING: May be habit forming)

Alcohol ..................................................................... 1.2%

In a palatable aromatic vehicle

Brompheniramine Maleate, USP: 2-Pyridinepropanamine,r-(4-bromophenyl)N, N-dimethyl-,(Z)-butenedioate(l:l).

Phenylpropanolamine Hydrochloride, USP: Benzenemethanol, a-(1-aminoethyl)-hydrochloride, (R*,S*)-( + ).

Codeine Phosphate, USP: Morphinan-6-01, 7,8,-didehydro-4,5-epoxy-3-methoxy-17- methyl-&,6a)-,phosphate (1:l) (salt), hemihydrate.

Antihistamine/Nasal Decongestan/Antitussive syrup for oral administratton.

INACTIVE INGREDIENTS: Citric Acid, USP; FD&C Blue No. 1; FD&C Red No. 40; Flavor; Glycerin, USP; Menthol, USP; Methylparaben, NF; Propylene Glycol, USP; Purified Water, USP; Sodium Benzoate, NF; Sodium Citrate, USP and Sorbitol Solution, USP.

The most frequent adverse reactions to this product are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include:

Dermatologic: Urticaria, drug rash, photosensitivity, pruritus.

Cardiovascular System: Hypotension, hypertension, cardiac arrhythmias.

CNS: Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, headache, euphoria and dysphoria.

G.U. System: Urinary frequency, difficult urination.

G.I. System: Epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.

Respiratory System: Tightness of chest and wheezing, shortness of breath. At higher doses, codeine has most of the disadvantages of morphine including respiratory depression.

Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.

DRUG ABUSE AND DEPENDENCE

Codeine can produce a drug dependence of the morphine type, and therefore has the potential for being abused. Psychic dependence, physical dependence, physical dependence and tolerance may develop upon repeated administration of this drug and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications.

The product is subject to the Federal Controlled Substances Act (Schedule V).

Brompheniramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Brompheniramine is used to treat runny nose, sneezing, itching, and watery eyes caused by allergies, the common cold, or the flu.

Brompheniramine may also be used for purposes not listed in this medication guide.

You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate.

Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, heart disease, or a thyroid disorder.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate.

Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, heart disease, or a thyroid disorder.

Ask a doctor or pharmacist if it is safe for you to take brompheniramine if you have:

• a blockage in your digestive tract (stomach or intestines), a colostomy or ileostomy;
• liver or kidney disease;
• cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;
• enlarged prostate or urination problems; or
• if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

FDA pregnancy category C. It is not known whether brompheniramine will harm an unborn baby. Do not use this medicine without medical advice if you are pregnant.

Brompheniramine may pass into breast milk and may harm a nursing baby. Antihistamines may also slow breast milk production. Do not use this medicine without medical advice if you are breast-feeding a baby.

Artificially sweetened cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

• Flowtuss

© Dimetane Patient Information is supplied by Cerner Multum, Inc. and Dimetane Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.