openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings and cautions
WARNINGS AND PRECAUTIONS Use with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes, narrow-angle glaucoma, or prostatic hypertrophy. Do not use in patients taking monoamine oxidase (MAO) inhibitors, or for 14 days after stopping treatment with an MAOI. Antihistamines should be used with considerable caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck obstruction. Antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients. Chlorpheniramine Maleate may cause excitability especially in children. Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child’s doctor. May cause drowsiness. Sedatives and tranquilizers may increase the drowsiness effect. Do not give this product to children who are taking sedatives or tranquilizers, without first consulting the child’s doctor. Dextromethorphan HBr is not indicated to relieve persistent or chronic coughs such as that which occurs with asthma or if the cough is accompanied by excessive phlegm (mucus), unless directed by a doctor. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. Phenylephrine HCl should not be used if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor. Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor.
ADVERSE REACTIONS Antihistamines may cause sedation, dizziness, diplopia, vomiting, diarrhea, dry mouth, headache, nervousness, nausea, anorexia, heartburn, weakness, polyuria and dysuria and, rarely, excitability in children. Urinary retention may occur in patients with prostatic hypertrophy. Sympathomimetic amines may cause convulsions, CNS stimulation, cardiac arrhythmias, respiratory difficulty, increased heart rate or blood pressure, hallucinations, tremors, nervousness, insomnia, weakness, pallor and dysuria. Dextromethorphan may cause drowsiness, dizziness, and GI disturbance.