Phenylephrine on USP-NF
This article was originally published in The Tan Sheet
Executive Summary
Bayer's Consumer Care division is "looking forward to" the inclusion of phenylephrine bitartrate in FDA's monograph for OTC Nasal Decongestant Products following the ingredient's Aug. 1 addition to the U.S. Pharmacopeia's National Formulary, Bayer says in a recent letter to FDA. The monograph amendment would apply to phenylephrine's use in effervescent tablets when used in combination with chlorpheniramine maleate and aspirin, and was proposed by FDA in November 2004 (1"The Tan Sheet" Nov. 8, 2004, p. 11). Phenylephrine's inclusion in the USP-NF is a prerequisite of its addition to the monograph. Bayer, which markets the Alka-Seltzer line of effervescent cough/cold products, submitted comments supporting the monograph amendment in February (2"The Tan Sheet" Feb. 14, 2005, p. 7)...