Approvals/FDA/Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride

Approved

HUMAN OTC DRUG LABEL

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Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride

SOFTGEL HEALTHCARE PRIVATE LIMITED🇺🇸 United States

FDA Page

Effective Date: Jan 28, 2026
Approval ID: 1fcbafaa-c871-db6d-e063-6394a90aab5e
Products: 1 registered
Version: 3

Regulatory Information

Labeling Type

HUMAN OTC DRUG LABEL

Status

Approved

Full Title

Acetaminophen 325 mg , Dextromethorphan Hydrobromide 10 mg, Doxylamine Succinate 6.25 mg and Phenylephrine Hydrochloride 5 mg (Night Time Severe)

Quick Stats

Total Products1

Labelers1

Label Sections17

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.