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OTC across-the-board sodium warning use makes "sense," FDA tells NDMA.

This article was originally published in The Tan Sheet

Executive Summary

OTC ACROSS-THE-BOARD SODIUM WARNING IMPLEMENTATION MAKES "SENSE," FDA told the Nonprescription Drug Manufacturers Association in a Jan. 14 letter responding to NDMA's Sept. 20 comments on sodium labeling for OTC drugs ("The Tan Sheet" Oct. 7, 1996, p. 22). The agency published a final rule setting sodium content labeling requirements for OTCs intended for oral ingestion in the April 22 Federal Register ("The Tan Sheet" April 29, 1996, p. 8).

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Content and warning label changes for calcium, magnesium, potassium and sodium dosages in orally ingested OTCs must be complied with by September 2005, according to two final rules published in the Federal Register March 24

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