Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
2 mg/5mL + 30 mg/5mL + 10 mg/5mL · Solution
- Prescription only
- Sigma-1 Agonist
- Active substance
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
- Made by
- PAI Holdings, LLC dba PAI Pharma
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2025-09-04
Sigma-1 Agonist
- Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with…
Adults and pediatric patients 12 years of age and over:: 10 mL (2 teaspoonfuls) every 4 hours.
Full directions ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-01
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- 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.
From the official label · 2025-09-04 · DailyMed
How it works
From this product’s own US prescribing label.
Brompheniramine maleate is a histamine antagonist, specifically an H1-receptor-blocking agent belonging to the alkylamine class of antihistamines.
Antihistamines appear to compete with histamine for receptor sites on effector cells.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-09-04
Do not take it if
- 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.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- 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.
Quoted from the official label, section “Dosage & Administration”.
Other 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.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Teratogenic Effects Animal reproduction studies have not been conducted with brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup.
- It is also not known whether brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
- It should be given to a pregnant woman only if clearly needed.
- Reproduction studies of brompheniramine maleate (a component of brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup) in rats and mice at doses up to 16 times the maximum human doses have revealed no evidence of impaired fertility or harm to the fetus.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Other medicines
- 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.
Quoted from the official label, section “Drug Interactions”.
Side effects
- 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.
Quoted from the official label, section “Adverse Reactions”.
How to store it
- 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.
Quoted from the official label, section “Storage and Handling”.
Details
| Made by | PAI Holdings, LLC dba PAI Pharma |
|---|---|
| Active substance | Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide |
| Used in | Breathing, airways, allergies and cough |
| Strength | 2 mg/5mL + 30 mg/5mL + 10 mg/5mL |
| Form | Solution |
| Route | Oral |
| Packs | 118 mL in 1 BOTTLE · 473 mL in 1 BOTTLE |
| NDC | 0121-0933 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
6 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Syrup5 products
2 mg/5mL + 30 mg/5mL + 10 mg/5mL5
2 mg/5mL + 30 mg/5mL + 10 mg/5mL · 5 companies
- Solution1 products
- 2 mg/5mL + 30 mg/5mL + 10 mg/5mL
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.