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.
Reported
Approval date2026-06-18
Acetaminophen dose325 mg
Butalbital dose50 mg