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FDA likely to reduce psyllium maximum daily dose to 14 g in upcoming laxative monograph.

This article was originally published in The Tan Sheet

Executive Summary

PSYLLIUM MAXIMUM DAILY DOSE EXPECTED TO BE REDUCED TO 14 G in the upcoming final monograph for OTC laxative products, according to FDA. In separate July 28 letters to the Nonprescription Drug Manufacturers Association and the U.S. Pharmacopeia, the agency said it plans to reduce the maximum daily dose for psyllium preparations from the 30 g recommended in the tentative final monograph to 14 g. FDA said the decision is based on industry comments as well as a review of the scientific literature and the psyllium-containing OTC laxatives currently on the market.

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