FDA label daca94bb-ea47-4007-ba4d-99332dc9fb31

WARNINGS: Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism and prostatic hypertrophy. Sympathomimetics may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Nervousness, dizziness or sleeplessness may occur at higher doses. Alkylamine-type antihistamines should be used with extreme caution in patients with narrow angle glaucoma; stenosing peptic ulcer; pyloroduodenal obstruction; symptomatic prostatic hypertrophy, or bladder neck obstruction. Due to its mild atropine-like action, chlorpheniramine should be used cautiously in patients with bronchial asthma, emphysema, or chronic pulmonary disease. May cause excitability, especially in children. Do not exceed recommended dosage.

ADVERSE REACTIONS: Pseudoephedrine may cause mild CNS 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. Sympathomimetic drugs have also been associated with certain untoward reactions including fear, anxiety, tenseness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucination, convulsion, CNS depression, arrhythmias and cardiovascular collapse with hypotension. 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.

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;