Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup is a clear, light pink-colored, butterscotch-flavored 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: 8mg/120mg/40mg / 20mL NDC: 70518-4526-00 NDC: 70518-4526-01 NDC: 70518-4526-02 NDC: 70518-4526-03 NDC: 70518-4526-04 NDC: 70518-4526-05 PACKAGING: 3 in 1 BOX PACKAGING: 20 mL in 1 CUP PACKAGING: 6 in 1 BOX PACKAGING: 10 mL in 1 CUP PACKAGING: 12 in 1 BOX PACKAGING: 5 mL in 1 CUP 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. Rx Only Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762; DRUG: Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide GENERIC: Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide DOSAGE: SYRUP ADMINSTRATION: ORAL NDC: 70518-4526-0 NDC: 70518-4526-1 NDC: 70518-4526-2 NDC: 70518-4526-3 NDC: 70518-4526-4 NDC: 70518-4526-5 COLOR: pink FLAVOR: BUTTERSCOTCH OUTER PACKAGING: 3 in 1 BOX PACKAGING: 20 mL in 1 CUP OUTER PACKAGING: 6 in 1 BOX PACKAGING: 10 mL in 1 CUP OUTER PACKAGING: 12 in 1 BOX PACKAGING: 5 mL in 1 CUP ACTIVE INGREDIENT(S): PSEUDOEPHEDRINE HYDROCHLORIDE 30mg in 5mL DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL BROMPHENIRAMINE MALEATE 2mg in 5mL INACTIVE INGREDIENT(S): ALCOHOL ANHYDROUS CITRIC ACID GLYCERIN METHYLPARABEN PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCROSE FD&C RED NO. 40 SODIUM CITRATE, UNSPECIFIED FORM MM1 MM2 MM3 MM4 MM5 MM6
- HOW SUPPLIED Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup is a clear, light pink-colored, butterscotch-flavored 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: 8mg/120mg/40mg / 20mL NDC: 70518-4526-00 NDC: 70518-4526-01 NDC: 70518-4526-02 NDC: 70518-4526-03 NDC: 70518-4526-04 NDC: 70518-4526-05 PACKAGING: 3 in 1 BOX PACKAGING: 20 mL in 1 CUP PACKAGING: 6 in 1 BOX PACKAGING: 10 mL in 1 CUP PACKAGING: 12 in 1 BOX PACKAGING: 5 mL in 1 CUP 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. Rx Only Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
- DRUG: Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide GENERIC: Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide DOSAGE: SYRUP ADMINSTRATION: ORAL NDC: 70518-4526-0 NDC: 70518-4526-1 NDC: 70518-4526-2 NDC: 70518-4526-3 NDC: 70518-4526-4 NDC: 70518-4526-5 COLOR: pink FLAVOR: BUTTERSCOTCH OUTER PACKAGING: 3 in 1 BOX PACKAGING: 20 mL in 1 CUP OUTER PACKAGING: 6 in 1 BOX PACKAGING: 10 mL in 1 CUP OUTER PACKAGING: 12 in 1 BOX PACKAGING: 5 mL in 1 CUP ACTIVE INGREDIENT(S): PSEUDOEPHEDRINE HYDROCHLORIDE 30mg in 5mL DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL BROMPHENIRAMINE MALEATE 2mg in 5mL INACTIVE INGREDIENT(S): ALCOHOL ANHYDROUS CITRIC ACID GLYCERIN METHYLPARABEN PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCROSE FD&C RED NO. 40 SODIUM CITRATE, UNSPECIFIED FORM MM1 MM2 MM3 MM4 MM5 MM6
Overview
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup is a clear, light pink syrup with a butterscotch flavor. Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate, USP ................. 2 mg Pseudoephedrine Hydrochloride, USP ........ 30 mg Dextromethorphan Hydrobromide, USP ...... 10 mg Alcohol 0.95% v/v In a palatable, aromatic vehicle. Inactive Ingredients: alcohol, artificial butterscotch flavor, citric acid anhydrous, glycerin, methylparaben, propylene glycol, purified water, sodium benzoate, sodium citrate, sucrose, and FD&C Red No. 40. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. The pH range is between 3.0 and 6.0. Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration. Chemical Structure 1 Chemical Structure 2 Chemical Structure 3
Indications & Usage
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 (MAOI) inhibitors ( 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 Oral 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.
Drug Interactions
Monoamine oxidase (MAO) inhibitors Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of MAO inhibitors and products containing dextromethorphan. In addition, MAO inhibitors 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 Oral Syrup and MAO inhibitors 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. Rx Only Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
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