Antacid Drug Products for Over-the-Counter Human Use; Proposed Amendment of Antacid Final Monograph

摘要

The Food and Drug Administration (FDA) is proposing to amend the final monograph for over-the-counter (OTC) antacid drug products to require specific indication, warning, and direction statements in the labeling of products containing sodium bicarbonate as an active ingredient. The new labeling would be required only for oral dosage forms intended to be dissolved in liquid prior to administration, such as powders and effervescent granules or tablets. As proposed, no such oral dosage forms containing sodium bicarbonate as an active ingredient would be allowed to make a claim for ``relief of overindulgence in food and drink.'' The proposed warnings would alert consumers to avoid antacid drug products containing sodium bicarbonate when the stomach is overly full from eating or drinking. The proposed directions would inform consumers that sodium bicarbonate should be completely dissolved before drinking and that the recommended dose should not be exceeded. FDA is issuing this notice of proposed rulemaking after receiving reports of gastric (stomach) rupture following ingestion of sodium bicarbonate to relieve gastrointestinal distress. This proposal is part of the ongoing review of OTC