Business · 02/02/1994Updated: 10/15/2026 · 1 min read
Antacid Drug Products for Over-the-Counter Human Use; Proposed Amendment of Antacid Final Monograph
Summary
The US Food and Drug Administration (FDA) is proposing to amend the final monograph for over-the-counter (OTC) antacid drug products to require specific labeling for products containing sodium bicarbonate, following reports of gastric rupture.
Original source language: Federal Register — Health and Human ServicesOpen original release →