Butalbital, Acetaminophen, Caffeine AND Codeine Phosphate

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Butalbital, Acetaminophen, Caffeine AND Codeine Phosphate (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for an existing combination analgesic; this is a regulatory action, not a clinical efficacy study.