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warnings and cautions
5 WARNINGS AND PRECAUTIONS Do not exceed recommended dosage. Discontinue use if adverse reactions occur. 5.1 General Before prescribing medication to suppress or modify cough, it is important to ascertain the underlying cause of the cough, that modification of cough does not increase the risk of clinical or physiological complications, and that appropriate therapy for the primary disease is instituted. 5.2 Special Risk Patients Use with caution in patients with diabetes, hypertension, or cardiovascular disease. Hypertensive crises can occur with concurrent use of MAO inhibitors (and for 14 days after stopping MAO inhibitor therapy), indomethacin, or with beta-blockers and methyldopa. If a hypertensive crisis occurs, these drugs should be discontinued immediately and therapy to lower blood pressure should be instituted. Antihistamines have an atropine-like action and therefore should be used with caution in patients with a history of bronchial asthma, increased intraocular pressure, hypothyroidism, cardiovascular disease and hypertension. Sympathomimetics may produce central nervous system stimulation with convulsions or cardio-vascular collapse with accompanying hypotension. Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism or prostatic hypertrophy.
6 ADVERSE REACTIONS Side effects may include drowsiness, dizziness, nervousness, insomnia, headache, palpitation, and dysuria. To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.