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Sodium phosphate enemas two-minute "time to effect" labeling recommended by NDMA.

This article was originally published in The Tan Sheet

Executive Summary

SODIUM PHOSPHATE ENEMAS TWO-MINUTE "TIME TO EFFECT" LABELING URGED by the Nonprescription Drug Manufacturers Association in Aug. 19 comments on FDA's proposed amendments to the OTC laxatives tentative final monograph. FDA has proposed revising or expanding directions for use on adult and pediatric sodium phosphate-containing oral dose laxatives, "time to effect" statements on rectal products, warnings on both types of products and revamping the professional labeling for oral and rectal products ("The Tan Sheet" May 25, p. 9). NDMA's comments do not pertain to professional labeling or orally administered products.
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