Phenylpropanolamine, Dextromethorphan and Brompheniramine

DESCRIPTION

Each 5 mL (one teaspoonful) contains:

Brompheniramine Maleate 2.0 mg
Dextromethorphan Hydrobromide 10 mg
Phenylpropanolamine Hydrochloride 12.5 mg

Brompheniramine Maleate, Dextromethorphan HBr and Phenylpropanolamine HCl is an alcohol free syrup with a black raspberry flavor.

Brompheniramine Maleate is an antihistaminic with the chemical name 2-[[p-Bromó-a-( amino)ethyl]benzyl]pyridine maleate (1:1), with the following molecular formula C₁₆H₁₉BrN₂•C₄H₄O₄, and a molecular weight of 435.32.

Dextromethorphan Hydrobromide is an antitussive with the chemical name 3-Methoxy-17-methy-9a, 13a, 1 4a-morphinan hydrobromide monohydrate, with the following molecular formula C₁₈H₂₅NO•HBr•H₂O, and a molecular weight of 370.33.

Phenylpropanolamine Hydrochloride is an adrenergic (vasoconstrictor) with the chemical name Benzene- methanol, cx-(1-aminoethyl)-, hydrochloride, (R*,S*), (-1-), with the following molecular formula C₉H₁₃NO•HCl, and a molecular weight of 187.67.

Inactive Ingredients: Citric Acid, D&C Red #33, deionized water, FD&C Blue #1, flavor, propylene glycol, saccharin sodium, sodium benzoate, sorbitol solution.

CLINICAL PHARMACOLOGY

Dextromethorphan hydrobromide acts centrally to elevate the threshold for coughing. It has no analgesic or addictive properties. The onset of antitussive action occurs in 15 to 30 minutes after administration and is of long duration. Phenylpropanolamine hydrochloride is a sympathomimetic drug which is readily absorbed from the gastrointestinal tract and produces nasal vasoconstriction (decongestion). Phenylpropanolamine stimulates both alpha and beta adrenergic receptors, similar to ephedrine. Part of its peripheral action is indirect and is due to the displacement of norepinephrine from storage sites, but it also has a direct effect on the adrenergic receptors. Brompheniramine maleate is a histamine antagonist, specifically an Hi-receptor blocking agent belonging to the alkyl amine class of antihistamines. Antihistamines appear to compete with histamine for receptor sites on effector cells. Brompheniramine also has anticholinergic (drying) and sedative effects. Among the antihistamine effects, it antagonizes the allergic response (vasodilation, increased vascular permeability, increased mucous secretion) of nasal tissue. Brompheniramine is well absorbed from the gastrointestinal tract, with peak plasma concentration after a single oral dose of 4 mg reached in 5 hours, urinary excretion is the major route of elimination, mostly as products of biodegradation; the liver is assumed to be the main site of metabolic transformation.

INDICATIONS

Brompheniramine Maleate, Dextromethorphan HBr and Phenylpropanolamine HCl Liquid is indicated for the relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

DOSAGE AND ADMINISTRATION

Adults: 2 teaspoonfuls every 4 hours.

Children: 6 to 12 years, 1 teaspoonful every 4 hours, 2 to 6 years 1/2 teaspoonful every 4 hours.

Do not exceed six doses in a 24 hour period.

Children under 2 years consult a physician.

HOW SUPPLIED

In bottles of 2 oz., oz., pint, gallon.

STORAGE Store at controlled room temperature, 15°-30°C (59°-86°F).

Dispense in tight, light-resistant container as defined in the USP/NF.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

SIDE EFFECTS

The most frequent adverse reactions to Brompheniramine Maleate, Dextromethorphan HBr and Phenylpropanolamine HCl Liquid include sedation, dryness of the mouth, nose and throat, thickening of bronchial secretions, and dizziness. Other adverse reactions may include:

• DERMATOLOGIC - Urticaria, drug rash photosensitivity and pruritus.
• CARDIOVASCULAR SYSTEM - Hypotension, hypertension, cardiac arrhythmias.
• CENTRAL NERVOUS SYSTEM - 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 or constipation.
• RESPIRATORY SYSTEM - Tightness of chest and wheezing, shortness of breath.
• HEMATOLOGIC SYSTEM - Hemolytic anemia, thrombocytopenia agranulocytosis.

DRUG INTERACTIONS

Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.). MAO inhibitors prolong and intensify the anticholemic (drying) effects of antihistamines. MAO inhibitors may enhance the effects of phenylpropanolamine. Sympathomimetics may reduce the effects of antihypertensive drugs.

WARNINGS

A persistent cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur or is accompanied by fever, rash or persistent headache, consult a physician. Do not take this product for persistent or chronic cough, such as occurs with smoking, asthma, emphysema or if cough is accompanied by excessive phlegm (mucous) unless directed by a physician. Especially in infants and small pediatric patients, antihistamines in overdosage may cause hallucinations, convulsions and death. Antihistamines may diminish mental alertness. In young pediatric patients, they may produce excitation.

PRECAUTIONS

General

Because of its antihistamine component, Brompheniramine Maleate, Dextromethorphan HBr and Phenylpropanolamine HCl Liquid should be used with caution in patients with a history of bronchial asthma, narrow angle glaucoma, gastrointestinal obstruction, or urinary bladder neck obstruction. Because of its sympathomimetic component, Brompheniramine Maleate, Dextromethorphan HBr and Phenylpropanolamine HCl Liquid should be used with caution in patients with diabetes, hypertension, heart disease, or thyroid disease.

Information for Patients

Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating dangerous machinery.

Drug Interactions

Antihistamines have effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.). MAO inhibitors prolong and intensify the anticholemic (drying) effects of antihistamines. MAO inhibitors may enhance the effects of phenylpropanolamine. Sympathomimetics may reduce the effects of antihypertensive drugs.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Animal studies of Brompheniramine Maleate, Dextromethorphan HBr and Phenylpropanolamine HCl Liquid to assess carcinogenic and mutagenic potential, or the effects on fertility have not been performed.

Pregnancy

Pregnancy Category C: Teratogenic Effects: Animal reproduction studies have not been conducted with Brompheniramine Maleate, Dextromethorphan HBr and Phenylpropanolamine HCl Liquid. It is also not known whether Brompheniramine Maleate, Dextromethorphan HBr and Phenylpropanolamine HCl Liquid can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Brompheniramine Maleate, Dextromethorphan HBr and Phenylpropanolamine HCl Liquid should be given to a pregnant woman only if clearly needed. Reproduction studies of brompheniramine maleate in rats and mice at doses up to 16 times the maximum human doses have revealed no evidence of impaired fertility or harm to the fetus.

Nursing Mothers

Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Brompheniramine Maleate, Dextromethorphan HBr and Phenylpropanolamine HCl Liquid is contraindicated in nursing mothers.