Butalbital, Acetaminophen, Caffeine and Codeine Phosphate

Breckenridge Pharmaceutical, Inc.🇺🇸 United States

FDA Page

Effective Date: Feb 8, 2024
Approval ID: d74db417-d2de-495b-bb75-46a83745603d
Products: 1 registered
Version: 10

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES safely and effectively. See full prescribing information for BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES. BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULES for oral use, CIII Initial U.S. Approval: 1992

Quick Stats

Total Products1

Labelers2

Label Sections40

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.