Uses
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
Source: US FDA prescribing information
Fixed-dose combination
Dextromethorphan and Promethazine
Also known as dextromethorphan hydrobromide, promethazine hydrochloride
Available on request
- Presentations
- 3
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Dextromethorphan and Promethazine is a fixed-dose combination of a phenothiazine, a sigma-1 agonist and an uncompetitive N-methyl-D-aspartate receptor antagonist. It is available as oral solution and syrup. MedsAcross supplies Dextromethorphan and Promethazine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Phenothiazine, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, Sigma-1 Receptor Agonists, Uncompetitive NMDA Receptor Antagonists
- US FDA first approval
- 3 December 1957
- EU status
- Not recorded
- Orphan designation
- Not recorded
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Oral
- Dosage forms
- Oral solution, Syrup
- Fixed-dose combination of
- Dextromethorphan, Promethazine
Clinical information
From the regulator-approved product information. Each section names its source.
Dosing overview
It is important that Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is measured with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose. Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is CONTRAINDICATED for children under 2 years of age. The average effective dose for adults is 5 mL (one teaspoon) every 4 to 6 hours, not to exceed 30.0 mL in 24 hours. For children 6 years to under 12 years of age, the dose is 2.5 to 5.0 mL (one-half to one teaspoon) every 4 to 6 hours, not to exceed 20.0 mL in 24 hours.
Source: US FDA prescribing information
Contraindications
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is contraindicated for use in pediatric patients less than two years of age. Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. Dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor.
Source: US FDA prescribing information
Warnings and precautions
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine in pediatric patients less than 2 years of age. Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine have resulted in respiratory depression in these patients.
Source: US FDA prescribing information
Side effects
PROMETHAZINE Central Nervous System – Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness, confusion, disorientation and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion, lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported. Cardiovascular – Increased or decreased blood pressure, tachycardia, bradycardia, faintness. Dermatologic – Dermatitis, photosensitivity, urticaria. Hematologic – Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. Gastrointestinal – Dry mouth, nausea, vomiting, jaundice.
Source: US FDA prescribing information
Interactions
Monoamine Oxidase (MAO) Inhibitors – Hyperpyrexia, hypotension, and death have been reported coincident with the co-administration of monoamine oxidase (MAO) inhibitors and products containing dextromethorphan. Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAO inhibitors and phenothiazines are used concomitantly. Thus, concomitant administration of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution and MAO inhibitors should be avoided.
Source: US FDA prescribing information
Storage
Store at 20° to 25°C (68° to 77°F). Protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
3 presentations of Dextromethorphan and Promethazine, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Dextromethorphan and Promethazine 15 mg/6.25 mg per 5 mL oral solutionOralGeneric name | Dextromethorphan and Promethazine | — | US FDA | Available on request |
| Dextromethorphan and Promethazine 15 mg/6.25 mg per 5 mL syrupOralGeneric name | Dextromethorphan and Promethazine | — | US FDA | Available on request |
| Promethazine DM 15 mg/6.25 mg per 5 mL oral solutionOral | Dextromethorphan and Promethazine | PAI Pharma | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 3 December 1957 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Questions and answers
Is Dextromethorphan and Promethazine available for export from India?
Yes, on request. MedsAcross lists 3 presentations of Dextromethorphan and Promethazine and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Dextromethorphan and Promethazine have?
The catalogue lists 1 brand names for Dextromethorphan and Promethazine, including Promethazine DM.
Is Dextromethorphan and Promethazine approved by the US FDA?
Yes. The US FDA first approved Dextromethorphan and Promethazine on 3 December 1957, according to Drugs@FDA.
Does Dextromethorphan and Promethazine need cold chain shipping?
No listed presentation of Dextromethorphan and Promethazine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
References
- Promethazine Hydrochloride and Dextromethorphan Hydrobromide prescribing information (ANI Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 8 August 2025
Request Dextromethorphan and Promethazine for export supply
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.