Brompheniramine, Pseudoephedrine, Dextromethorphan 2 mg/5mL
Brompheniramine, Pseudoephedrine, Dextromethorphan · SYRUP · Ascend Laboratories, LLC
Brompheniramine, Pseudoephedrine, Dextromethorphan is a syrup containing brompheniramine, pseudoephedrine, dextromethorphan at 2 mg/5mL, taken oral. Manufactured by Ascend Laboratories, LLC.
Key Facts
- Brand Name
- Brompheniramine, Pseudoephedrine, Dextromethorphan
- Generic Name
- Brompheniramine, Pseudoephedrine, Dextromethorphan
- NDC Code (Product)
67877-558- Manufacturer
- Ascend Laboratories, LLC
- Strength
- 2 mg/5mL
- Dosage Form
- SYRUP
- Route
- ORAL
- Marketing Status
- Application #
- ANDA210647
- Marketing Start
- 01/05/2026
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS & USAGE For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
Dosage & Administration
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
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 (MAOI) inhibitors (see PRECAUTIONS - Drug Interactions ). Antihistamines should not be used to treat lower respiratory tract conditions including asthma.
Drug Interactions
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 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.
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.
Frequently Asked Questions
What is Brompheniramine, Pseudoephedrine, Dextromethorphan used for?
Brompheniramine, Pseudoephedrine, Dextromethorphan contains Brompheniramine, Pseudoephedrine, Dextromethorphan. It is a syrup taken oral. Consult your doctor for specific uses.
Is Brompheniramine, Pseudoephedrine, Dextromethorphan a controlled substance?
Brompheniramine, Pseudoephedrine, Dextromethorphan is not classified as a controlled substance by the DEA.
What is the generic name for Brompheniramine, Pseudoephedrine, Dextromethorphan?
The generic name for Brompheniramine, Pseudoephedrine, Dextromethorphan is Brompheniramine, Pseudoephedrine, Dextromethorphan. There are no other listed brand versions of Brompheniramine, Pseudoephedrine, Dextromethorphan.
What is the NDC code for Brompheniramine, Pseudoephedrine, Dextromethorphan 2 mg/5mL?
The NDC (National Drug Code) for Brompheniramine, Pseudoephedrine, Dextromethorphan 2 mg/5mL is 67877-558, listed by Ascend Laboratories, LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)