OTC antacid/antiflatulent labeling
FDA is proposing to exempt all products, except those containing busmuth, from the monograph-required statement that "in case of accidental overdose, seek professional assistance or contact a poison control center." Agency said that it agreed with submitted petitions that all ingredients used in the products, except bismuth, have a "low potential for acute toxicity" from accidental ingestion, according to a proposed rule in the April 13 Federal Register.
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