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In Brief: OTC drug labeling

This article was originally published in The Rose Sheet

Executive Summary

OTC drug labeling: FDA is extending by 60 days the comment period for a final rule on sodium labeling and for a notice of proposed rulemaking on the labeling of oral OTC products containing calcium, magnesium and potassium, until Sept. 20. The extension was given at the request of the Nonprescription Drug Manufacturers Association. Both the final rule, which amends existing regulation to include sodium content labeling for products including dentifrice, mouthwashes and mouthrinse products, and the NPR were originally published in the April 22 Federal Register...
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