FDA label 11437a1c-9d21-4e46-a9ea-0786197ee4a0

WARNINGS Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. Sympathomimetic amines should be used with 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. Nervousness, dizziness or sleeplessness may occur at higher doses. Hypertensive crises can occur with concurrent use of pseudoephedrine and MAOI, 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. Fever should be managed by means of external cooling. Do not exceed recommended dosage.

ADVERSE REACTIONS Pseudoephedrine may cause mild central nervous system stimulation, especially in those patients who are hypersensitive to sympathomimetic drugs. Nervousness, excitability, restlessness, dizziness, weakness and insomnia may also occur. Headache and drowsiness have also been reported. Large doses may cause lightheadedness, nausea and/or vomiting. Sympathomimetics 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. Adverse effects associated with dextromethorphan are generally infrequent and mild. Products containing dextromethorphan have been associated with nausea, dizziness, fatigue, gastrointestinal disturbances, and skin eruptions. Chlorpheniramine may cause slight to moderate drowsiness and is the most frequent side effect. Other possible side effects of antihistamines include: General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat; Cardiovascular: Hypotension, headache, palpitation, tachycardia, extra systoles; Hematological: Hemolytic anemia, thrombocytopenia, agranulocytosis; CNS: Sedation, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, hysteria, neuritis, convulsion; Gastrointestinal: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation; Genitourinary: Urinary frequency, difficult urination, urinary retention, early menses; Respiratory: Thickening of bronchial secretions, tightness of chest, wheezing and nasal stuffiness.