Antacid Drug Products for Over-The-Counter Human Use; Proposed Amendment of Final Monograph; Reopening of Comment Period

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The Food and Drug Administration (FDA) is reopening to May 4, 1994, the comment period on the notice of proposed rulemaking that would require specific indication, warning, and direction statements in the labeling of over-the-counter (OTC) antacid drug products containing sodium bicarbonate as an active ingredient (February 2, 1994, 59 FR 5060). 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.