JUL 16, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Ibuprofen AND Famotidine (Labeling)
U.S. Food and Drug Administration
FDA supplemental approval for labeling of a fixed-dose combination product; regulatory action does not contain clinical trial data or efficacy evidence.
Reported
Ibuprofen dose800 mg
Famotidine dose26.6 mg
Approval date2026-07-16