FDA label
What is promethazine and dextromethorphan used for?
The FDA-approved uses of promethazine and dextromethorphan, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “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.”
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Promethazine Hydrochloride and Dextromethorphan Hydrobromide, solution
Indications and Usage, quoted from the label by Camber Pharmaceuticals, Inc. (ANDA218264). Cross-references to other label sections are left out.
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: DailyMed label, set id 6a2cd2d6-6e0f-4b2d-be7a-8b99627f4453, version 1, effective June 9, 2026. NDC 31722-692, one of 7 listings for this product.
Promethazine Hydrochloride and Dextromethorphan Hydrobromide, syrup
Indications and Usage, quoted from the label by Atlantic Biologicals Corp. (ANDA088864). Cross-references to other label sections are left out.
Promethazine hydrochloride and dextromethorphan hydrobromide syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
Source: DailyMed label, set id 5022379d-05ef-63f2-e063-6294a90a2189, version 1, effective April 23, 2026. NDC 17856-4024, one of 4 listings for this product.
Questions
What is promethazine and dextromethorphan used for?
The FDA label says: “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.”
What drug class is promethazine and dextromethorphan?
FDA lists promethazine and dextromethorphan in the Phenothiazine and Sigma-1 Agonist and Uncompetitive N-methyl-D-aspartate Receptor Antagonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Promethazine and Dextromethorphan
- Is Promethazine and Dextromethorphan a controlled substance?Federal schedule
- Phenothiazines listFDA drug class
- Sigma-1 Agonists listFDA drug class
- Uncompetitive N-methyl-D-aspartate Receptor Antagonists listFDA drug class
- NDC 0116-4024Promethazine and Dextromethorphan NDC record
- NDC 0121-1070Promethazine and Dextromethorphan NDC record
- NDC 0713-0780Promethazine and Dextromethorphan NDC record