Each flat, quadri-scored, embossed "107", purple tablet, 6mm thick and 10mm in diameter contains:
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Pregelatinized Starch, crospovidone, povidone, stearic acid, magnesium stearate, FD&C blue #1, aluminum lake and D&C red #27 aluminum lake.
Acetaminophen produces analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat-regulating center. Phenylpropanolamine HCl is a sympathomimetic and is a vasoconstrictor with decongestive action on nasal and upper respiratory tract mucous membranes. Chlorpheniramine maleate is an alkylamine antihistamine which possesses anticholinergic and sedative effects.
Symptomatic relief and reduction of fever or relief of pain in common upper respiratory infections; allergic rhinitis; vasomotor rhinitis. Pediatric use: Safety and effectiveness in pediatric patients have not been established.
Hypersensitivity to any of the ingredients; cardiac disease; hypertension; patients receiving MAO inhibitors; hyper-thyroidism.
Alumadrine tablets may increase the effects of alcohol and other CNS depressants. Do not take simultaneously with other products containing Phenylpropanolamine HCl.
General: Use cautiously in patients with glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy, bladder neck obstruction, diabetes. Withdraw medication if restlessness or nervousness occurs or if high fever persists. Information for patients: Because this product may cause drowsiness or blurring of vision, patients should be cautioned against driving or operating machinery. Also caution patients of the added effects of alcohol and other CNS depressants. Pregnancy: Pregnancy Category C. It is not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only if clearly needed. Nursing Mothers: It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat. Cardiovascular: Hypotension, hypertension, headache, palpitations, tachycardia, extrasystoles and angina pain. Hematologic: Hemolytic anemia, thrombocytopenia, agranulocytosis, leukopenia. CNS: Sedation, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria neuritis and convulsions. GI: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation. GU: Urinary frequency, urinary difficulty or retention, early menses. Respiratory: Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.
The stomach should be emptied promptly by lavage or by induction of emesis.
Adults--Two tablets initially, then one tablet every four hours. Do not exceed 6 tablets in 24 hours.
Supplied as quadri-scored, embossed "107", purple tablets, in bottles of 100, NDC 0256-0107-01.
Rev. 8/99