JUN 18, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Acetaminophen AND Codeine Phosphate (REMS)
U.S. Food and Drug Administration
FDA supplemental approval for a Risk Evaluation and Mitigation Strategy (REMS) for an acetaminophen–codeine combination oral solution; regulatory action that affects product labelling and use conditions, not a clinical evidence assessment.
Reported
Approval status date2026-06-18
Acetaminophen concentration120 mg/5 mL
Codeine phosphate concentration12 mg/5 mL