JUN 10, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Acetaminophen AND Ibuprofen Back Pain (Labeling)
U.S. Food and Drug Administration
FDA supplemental approval for labeling of a fixed-dose combination product; does not contain clinical trial data or efficacy evidence.
Reported
Acetaminophen dose250 mg
Ibuprofen dose125 mg
Approval date2026-06-10