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.

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.

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