Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is a clear, sweet, unflavored, pink syrup containing in each 5 mL (1 teaspoonful) brompheniramine maleate 2 mg, pseudoephedrine hydrochloride 30 mg and dextromethorphan hydrobromide 10 mg, available in the following sizes: NDC 0121-0933-04: 4 fl oz (118 mL) bottle NDC 0121-0933-16: 16 fl oz (473 mL) bottle RECOMMENDED STORAGE Store at 20° to 25°C (68 ° to 77 °F) [See USP Controlled Room Temperature] . KEEP TIGHTLY CLOSED Dispense in a tight, light-resistant container as defined in the USP.; PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label NDC 0121- 0933 -04 Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution (2 mg/30 mg/10 mg/ per 5 mL) Alcohol Free٠Sweet٠Unflavored Each 5 mL (teaspoonful) contains: Brompheniramine Maleate, USP ......................... 2 mg Pseudoephedrine Hydrochloride, USP ............... 30 mg Dextromethorphan Hydrobromide, USP............... 10 mg Rx only 4 FL OZ (118 mL) PAI Pharma Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup, 2 mg/30 mg/10 mg/ per 5 mL 4fl oz bottle; PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 0121- 0933 -16 Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution (2 mg/30 mg/10 mg/ per 5 mL) Alcohol Free٠Sweet٠Unflavored Each 5 mL (teaspoonful) contains: Brompheniramine Maleate, USP ......................... 2 mg Pseudoephedrine Hydrochloride, USP ............... 30 mg Dextromethorphan Hydrobromide, USP............... 10 mg Rx only 16 FL OZ (473 mL) PAI Pharma Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup, 2 mg/30 mg/10 mg per 5 mL 16 fl oz bottle
- HOW SUPPLIED Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup is a clear, sweet, unflavored, pink syrup containing in each 5 mL (1 teaspoonful) brompheniramine maleate 2 mg, pseudoephedrine hydrochloride 30 mg and dextromethorphan hydrobromide 10 mg, available in the following sizes: NDC 0121-0933-04: 4 fl oz (118 mL) bottle NDC 0121-0933-16: 16 fl oz (473 mL) bottle RECOMMENDED STORAGE Store at 20° to 25°C (68 ° to 77 °F) [See USP Controlled Room Temperature] . KEEP TIGHTLY CLOSED Dispense in a tight, light-resistant container as defined in the USP.
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label NDC 0121- 0933 -04 Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution (2 mg/30 mg/10 mg/ per 5 mL) Alcohol Free٠Sweet٠Unflavored Each 5 mL (teaspoonful) contains: Brompheniramine Maleate, USP ......................... 2 mg Pseudoephedrine Hydrochloride, USP ............... 30 mg Dextromethorphan Hydrobromide, USP............... 10 mg Rx only 4 FL OZ (118 mL) PAI Pharma Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup, 2 mg/30 mg/10 mg/ per 5 mL 4fl oz bottle
- PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 0121- 0933 -16 Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution (2 mg/30 mg/10 mg/ per 5 mL) Alcohol Free٠Sweet٠Unflavored Each 5 mL (teaspoonful) contains: Brompheniramine Maleate, USP ......................... 2 mg Pseudoephedrine Hydrochloride, USP ............... 30 mg Dextromethorphan Hydrobromide, USP............... 10 mg Rx only 16 FL OZ (473 mL) PAI Pharma Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup, 2 mg/30 mg/10 mg per 5 mL 16 fl oz bottle
Overview
Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup is a clear, sweet, unflavored, pink syrup. Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate, USP 2 mg Pseudoephedrine Hydrochloride, USP 30 mg Dextromethorphan Hydrobromide, USP 10 mg Inactive Ingredients: citric acid anhydrous, FD&C Red #40, glycerin, methylparaben, purified water, sodium benzoate, sodium citrate dihydrate, and sucrose. Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration. Brompheniramine Maleate, USP chemical structure Pseudoephedrine Hydrochloride, USP chemical structure Dextromethorphan Hydrobromide, USP chemical structure
Indications & Usage
Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
Dosage & Administration
Adults and pediatric patients 12 years of age and over: 10 mL (2 teaspoonfuls) every 4 hours. Children 6 to under 12 years of age: 5 mL (1 teaspoonful) every 4 hours. Children 2 to under 6 years of age: 2.5 mL (½ teaspoonful) every 4 hours. Infants 6 months to under 2 years of age: Dosage to be established by a physician. Do not exceed 6 doses during a 24-hour period.
Warnings & Precautions
WARNINGS Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death. Antihistamines may diminish mental alertness. In the young child, they may produce excitation.
Contraindications
Hypersensitivity to any of the ingredients. Do not use in the newborn, in premature infants, in nursing mothers, or in patients with severe hypertension or severe coronary artery disease. Do not use dextromethorphan in patients receiving monoamine oxidase inhibitors (MAOI) (see PRECAUTIONS - Drug Interactions ). Antihistamines should not be used to treat lower respiratory tract conditions including asthma.
Adverse Reactions
The most frequent adverse reactions to brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include: Dermatologic: Urticaria, drug rash, photosensitivity, pruritus. Cardiovascular System: Hypotension, hypertension, cardiac arrhythmias, palpitation. CNS: Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, headache, euphoria, and dysphoria. G.U. System: Urinary frequency, difficult urination. G.I. System: Epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation. Respiratory System: Tightness of chest and wheezing, shortness of breath. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis. Respiratory System: Tightness of chest and wheezing, shortness of breath. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis. To report SUSPECTED ADVERSE REACTIONS, contact PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or HYPERLINK "http://www.fda.gov/medwatch" www.fda.gov/medwatch.
Drug Interactions
Monoamine oxidase inhibitors (MAOI) Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of MAOI and products containing dextromethorphan. In addition, MAOI prolong and intensify the anticholinergic (drying) effects of antihistamines and may enhance the effect of pseudoephedrine. Concomitant administration of brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup and MAOI should be avoided (see CONTRAINDICATIONS ). Central nervous system (CNS) depressants Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.). Antihypertensive drugs Sympathomimetic may reduce the effects of antihypertensive drugs.
Storage & Handling
RECOMMENDED STORAGE Store at 20° to 25°C (68 ° to 77 °F) [See USP Controlled Room Temperature] . KEEP TIGHTLY CLOSED Dispense in a tight, light-resistant container as defined in the USP.
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