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SODIUM PHOSPHATE/SODIUM BIPHOSPHATE LAXATIVE LABEL WARNING PROPOSED BY FDA

This article was originally published in The Tan Sheet

Executive Summary

SODIUM PHOSPHATE/SODIUM BIPHOSPHATE LAXATIVE LABEL WARNING PROPOSED BY FDA in a notice of proposed rulemaking published in the March 31 Federal Register. The agency explained that it is amending the tentative final monograph for OTC laxatives to add a warning for "all sodium phosphate/sodium biphosphate products not to exceed the recommended dosage unless directed by a doctor" due to adverse reactions and deaths associated with those products.

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