Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate

Softgel Healthcare Private Limited🇺🇸 United States

FDA Page

Effective Date: Apr 27, 2026
Approval ID: 353f71f7-81e0-08c2-e063-6294a90acb49
Products: 1 registered
Version: 5

Regulatory Information

Labeling Type

HUMAN OTC DRUG LABEL

Status

Approved

Full Title

Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Doxylamine Succinate 6.25 mg Capsules (Night Severe)

Quick Stats

Total Products1

Labelers1

Label Sections15

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.