Butalbital, Acetaminophen, Caffeine, AND Codeine Phosphate

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Fioricet With Codeine (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 evidence report.

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 for a Risk Evaluation and Mitigation Strategy (REMS) on an existing combination analgesic; regulatory actions do not report clinical trial data and do not establish efficacy or comparative benefit.