Article: New directions for bulk laxatives proposed.

New Directions for Bulk Laxatives Proposed

New directions for using bulk laxatives have been spelled out in a proposed amendment to the tentative final monograph for over-the-counter laxatives.

In the proposed monograph, published in January 1985, FDA stated that where the advisory review panel recommended a daily dose of an ingredient without a dosage interval, it was assumed this meant a single daily dose. However, the agency has since found that the maximum daily dose of bulk laxatives is routinely administered in divided doses. In addition, the maximum daily ...

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