FDA label 7d8eba2b-d69b-4b54-9ad1-d6f4dde632f4

WARNINGS Do not exceed the recommended dosage. Patients with persistent cough such as occur with smoking, asthma, emphysema, or where cough is accompanied by excessive secretions should not take this product. A persistent cough may be a sign of a serious condition. If the cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. Use caution when giving to children or patients with chronic pulmonary disease, shortness of breath, difficulty in breathing, asthma, emphysema, high blood pressure, heart disease, diabetes, thyroid disease, or difficulty in urination due to enlargement of the prostate gland unless directed by a physician. Antihistamines may impair mental and physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery, and may impair mental alertness in children. Antihistamines may cause hyperexcitability, especially in children. At doses higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur. Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. Administration of Dextromethorphan Hydrobromide may be accompanied by histamine release and should be used with caution in atopic children. If a hypertensive crisis occurs, these drugs should be discontinued immediately and therapy to lower blood pressure should be instituted immediately. Fever should be managed by means of external cooling.

ADVERSE REACTIONS The most frequent adverse reactions to BPM Mal/PSE HCl/DM HBr 4/20/20mg/5 mL include sedation; dryness of mouth, nose, and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include: General: urinary, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose, and throat. Cardiovascular System: hypotension, headache, palpitations, tachycardia, extra systoles. Dermatologic: urticaria, drug rash, photosensitivity, and pruritus. Central Nervous System: sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions. Gastrointestinal: epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation. Genitourinary: urinary frequency, difficult urination, urinary retention, early mensea. Respiratory: thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness. Hematologic System: hemolytic anemia, thrombocytopenia, agranulocytosis.