FDA label 493d4c78-01d6-4385-8fc4-42f79bd62642

WARNINGS Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, patients should discontinue use and consult a physician. Patients should consult their physician if they have heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland. Dexchlorpheniramine maleate should be used with caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, or bladder neck obstruction. Due to its mild atropine-like action, dexchlorpheniramine maleate should be used cautiously in patients with bronchial asthma. Patients should not take this product, unless directed by their physician, if they have a breathing problem such as emphysema or chronic bronchitis, or if they have glaucoma. Antihistamines may diminish mental alertness. Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive acetaminophen use, although reports of this event are rare. Reports almost invariably involve cases of severe chronic alcoholics and the dosages of acetaminophen most often exceed recommended doses and often involve substantial overdose. Professionals should alert their patients who regularly consume large amounts of alcohol not to exceed recommended doses of acetaminophen.

ADVERSE REACTIONS Dexchlorpheniramine Maleate Slight to moderate drowsiness may occur and is the mo 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, extrasystoles; Hematologic: hemolytic anemia, thrombocytopenia, granulocytosis; 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. Pseudoephedrine HCI 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. 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.