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BROMPHENIRAMINE, PSEUDOEPHEDRINE & DEXTROMETHORPHAN SYRUP 2MG/30MG/10MG/5ML 473 ML

Generic: Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide

NDC:42192-0607-16

Manufacturer:Acella Pharmaceuticals, LLC

Strength:2 mg/5mL, 10 mg/5mL, 30 mg/5mL

Dosage Form:SYRUP

Route:ORAL

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Drug Information

Identification

Generic Name

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide

Brand Name

Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide

Labeler / Distributor

Acella Pharmaceuticals, LLC

Product Type

HUMAN PRESCRIPTION DRUG

Administration

Dosage Form

SYRUP

Route of Administration

ORAL

FDA Application Number

ANDA203375

Active Ingredients

Ingredient	Strength
BROMPHENIRAMINE MALEATE	2 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/5mL
PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg/5mL

Pharmacological Class

Adrenergic alpha-Agonists [MoA]Sigma-1 AgonistSigma-1 Receptor Agonists [MoA]Uncompetitive N-methyl-D-aspartate Receptor AntagonistUncompetitive NMDA Receptor Antagonists [MoA]alpha-Adrenergic Agonist

Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.

Wholesale compliance resources

DSCSA T2 documents DSCSA compliance resource hub

Drug Resources

Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide Drug Page NDC 42192-0607-16 Lookup

Clinical Drug Information

Indications & Usage

INDICATIONS AND 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.

Warnings

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.

Dosage & Administration

DOSAGE AND 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.

Adverse Reactions

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.

Information for Patients

Information for Patients: Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating dangerous machinery.

Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.