OTC PEDIATRIC DOSING FOR COUGH/COLD COMBINATION PRODUCTS
This article was originally published in The Tan Sheet
Executive Summary
OTC PEDIATRIC DOSING FOR COUGH/COLD COMBINATION PRODUCTS is still being considered as a topic for a future Nonprescription Drugs Advisory Committee meeting, OTC Monograph Review Staff Director William Gilbertson, PharmD, told industry representatives at a July 12 "OTC feedback" meeting. Indicating that cough/cold combination products may be the focus of the pediatric labeling discussion, Gilbertson said FDA is considering "taking this issue for resolution to the nonprescription drags advisory panel... because [the cough/cold combination final monograph] is a very complex document."