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warnings
WARNINGS Antihistamines may diminish mental alertness, and may cause hyperexcitability, especially in children. At doses higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur. Do not exceed the recommended dosage. Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death. Do not give this product to children who have a chronic pulmonary disease, breathing problems such as chronic bronchitis, glaucoma, or those who are taking sedatives or tranquilizers without first consulting with a doctor. Considerable caution should be exercised in patients with hypertension, diabetes, ischemic heart disease, hyperthyroidism, increased intraocular pressure, renal impairment, and prostatic hypertrophy.
ADVERSE REACTIONS The most frequent adverse reactions include: sedation; drowsiness; dryness of mouth, nose, and throat; thickening of bronchial secretions; and dizziness. Other adverse reactions may include: Dermatologic – urticaria, drug rash, photosensitivity, pruritus. Cardiovascular System – hypotension, hypertension, cardiac arrhythmias, palpitations, increased heart rate or blood pressure. Central Nervous System (CNS) – disturbed coordination, tremor, irritability, excitability, insomnia, visual disturbances such as diplopia, weakness, nervousness, hallucination, pallor, convulsion, headache, euphoria, and dysphoria. G.U. System – urinary frequency, difficult urination. G.I. System – epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation. Respiratory System – tightness of chest and wheezing, shortness of breath. Hematologic System – hemolytic anemia, thrombocytopenia, agranulocytosis. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.