FDA label 5649ad9f-14c7-5e65-e054-00144ff88e88

WARNINGS: Pyrilamine Maleate and Chlorpheniramine Maleate: Antihistamines should be used with considerable caution in patients with narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, and bladder neck obstruction. In infants and children especially, antihistamine overdosage may cause hallucinations, convulsions or death. As in adults, antihistamines may diminish mental alertness in children. Chlorpheniramine Maleate has additional effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers) Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating appliances, machinery, etc. Phenylephrine Hydrochloride: Sympathomimetic amines should be used with considerable caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. DO NOT EXCEED RECOMMENDED DOSAGE. Hypertensive crisis could occur with concurrent use of phenylephrine and monoamine oxidase (MAO) inhibitors, indomethacin or with beta blockers and methyldopa. If a hypertensive crisis occurs, this drug should be discontinued immediately and therapy to lower blood pressure should be instituted. Fever should be managed by means of external cooling. The elderly (approximately sixty years or older) are more likely to have adverse reactions to sympathomimetics. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression and death. Therefore, safe use of a short-acting sympathomimetic should be demonstrated in the individual elderly patient before considering the use of a sustained-release formulation. Discontinue use if adverse reaction(s) occur.

ADVERSE REACTIONS: Pyrilamine Maleate and Chlorpheniramine Maleate: Chlorpheniramine maleate may cause slight to moderate drowsiness relatively infrequently. Other possible side effects of antihistamines in general include: urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness or the mouth, nose and throat; cardiovascular effects (hypotension, headache, palpitation, tachycardia, extrasystoles); hematological effects (hemolytic anemia, thrombocytopenia, agranulocytosis); CNS disturbances (sedation, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions); gastrointestinal effects (epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation); genitourinary effects (urinary frequency, difficult urination, urinary retention, early menses) and respiratory effects (thickening of bronchial secretions, tightness of the chest, wheezing and nasal stuffiness). Phenylephrine Hydrochloride: Hyper-reactive individuals may display ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness, or nausea. Sympathomimetic amines have been associated with certain untoward reactions including fear, anxiety, nervousness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias, and cardiovascular collapse with hypotension. Phenylephrine may cause precordial pain, respiratory distress, tremor, weakness, hypertension, restlessness, anxiety, nervousness and dizziness.