Laxative Drug Products for Over-the-Counter Human Use; Proposed Amendment to the Tentative Final Monograph

Résumé

The Food and Drug Administration (FDA) is amending the tentative final monograph for over-the-counter (OTC) laxative drug products to include additional general and professional labeling for oral and rectal dibasic sodium phosphate/monobasic sodium phosphate (sodium phosphates) drug products. FDA is proposing new warnings and directions for these products and a new time to effect statement for rectal products based on new data submitted after publication of the tentative final monograph for OTC laxative drug products. This proposal is part of the ongoing review of OTC drug products conducted by FDA. Elsewhere in this issue of the Federal Register the agency is finalizing the package size limitation and warning prior to the completion of the final monograph for OTC laxative drug products.