Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Proposed Amendment to Tentative Final Monograph; Reopening of Comment Period

概要

The Food and Drug Administration (FDA) is reopening to May 4, 1994, the comment period on the notice of proposed rulemaking pertaining to combinations of over-the-counter (OTC) internal analgesic and antacid ingredients, specifically sodium bicarbonate used as an antacid active ingredient (February 2, 1994, 59 FR 5068). FDA is taking this action in response to a request to extend the comment period for an additional 30 days to allow more time to comment on this proposal. The comment period for these issues closed on April 4, 1994. This proposal is part of the ongoing review of OTC drug products conducted by FDA.