Drugplain

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide 2 mg/5mL

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide · SYRUP · Bryant Ranch Prepack

2 Recalls on Record
Plain English

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide is a syrup containing brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide at 2 mg/5mL, taken oral. Manufactured by Bryant Ranch Prepack.

Key Facts

Brand Name
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
Generic Name
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
NDC Code (Product)
72162-1123
Manufacturer
Bryant Ranch Prepack
Strength
2 mg/5mL
Dosage Form
SYRUP
Route
ORAL
Marketing Status
Application #
ANDA205292
Marketing Start
02/06/2015

Recall History

2 Recalls on Record
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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.

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.

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.

Contraindications

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.

Drug Interactions

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.

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. 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.

Frequently Asked Questions

What is Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide used for?

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide contains Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide. It is a syrup taken oral. Consult your doctor for specific uses.

Is Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide a controlled substance?

Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide is not classified as a controlled substance by the DEA.

What is the generic name for Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide?

The generic name for Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide is Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide. There are no other listed brand versions of Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide.

What is the NDC code for Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide 2 mg/5mL?

The NDC (National Drug Code) for Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide 2 mg/5mL is 72162-1123, listed by Bryant Ranch Prepack.

Product NDC

72162-1123

Package NDC

72162-1123-2

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)