Acetaminophen AND Codeine Phosphate

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Acetaminophen AND Codeine Phosphate (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for an existing acetaminophen-codeine combination product; this is a regulatory action, not a clinical efficacy trial.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Acetaminophen AND Codeine Phosphate (REMS)

U.S. Food and Drug Administration

FDA supplemental approval action for an existing drug-drug combination product with REMS requirements; does not report clinical trial data or comparative efficacy.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Acetaminophen AND Codeine Phosphate (REMS)

U.S. Food and Drug Administration

FDA supplemental approval action for a risk evaluation and mitigation strategy (REMS) affecting acetaminophen–codeine combination products; does not report clinical trial data.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Acetaminophen AND Codeine Phosphate (REMS)

U.S. Food and Drug Administration

FDA supplemental approval for REMS (Risk Evaluation and Mitigation Strategy) on acetaminophen–codeine phosphate tablets; confirms regulatory compliance but does not report clinical efficacy or comparative benefit data.