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In Brief: Ipecac exemption from OTC alcohol limits

This article was originally published in The Tan Sheet

Executive Summary

Ipecac exemption from OTC alcohol limits: FDA proposes to amend regs for oral OTCs containing alcohol as an inactive ingredient by exempting ipecac syrup from the maximum concentration limits of .5% alcohol or less when used by children under six. Even if a child swallowed the entire contents of a 30 ml container of ipecac, "the ingested amount of alcohol (.75 ml) is insignificant," the agency said, and the alcohol and syrup usually are vomited along with the other stomach contents. "The benefit of ipecac syrup as an emetic outweighs any risk of adverse effects from ingestion of .75 ml of alcohol," the agency concludes. The notice of proposed rulemaking appears in the May 10 Federal Register. Written comments are due June 10...
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