BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE

Bryant Ranch Prepack🇺🇸 United States

FDA Page

Effective Date: May 27, 2026
Approval ID: 95a33c9b-79a6-47c7-8433-fc217950b88f
Products: 1 registered
Version: 16

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ASCOMP with Codeine safely and effectively. See full prescribing information for ASCOMP with Codeine. ASCOMP with Codeine (butalbital, aspirin, caffeine, and codeine phosphate, USP) capsules, for oral use, CIII Initial U.S. Approval: 1990

Quick Stats

Total Products1

Labelers2

Label Sections42

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.