JUN 18, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Tramadol Hydrochloride AND Acetaminophen (REMS)
U.S. Food and Drug Administration
FDA supplemental approval of a fixed-dose tramadol–acetaminophen combination tablet with REMS requirements; this is a regulatory action, not a clinical efficacy study.
Reported
Approval date2026-06-18
Tramadol hydrochloride dose37.5 mg
Acetaminophen dose325 mg