Promethazine Hydrochloride and Dextromethorphan Hydrobromide

Asclemed USA, Inc.🇺🇸 United States

FDA Page

Effective Date: May 7, 2025
Approval ID: 702eb7c0-db4c-4729-b69e-99f64c63c7bd
Products: 1 registered
Version: 2

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution Rx Only

Quick Stats

Total Products1

Labelers2

Label Sections12

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.