OTC NASAL DECONGESTANT LABEL WARNING FOR POTENTIAL "REBOUND" EFFECT
This article was originally published in The Tan Sheet
Executive Summary
OTC NASAL DECONGESTANT LABEL WARNING FOR POTENTIAL "REBOUND" EFFECT will be required for all topical products under FDA's final monograph for OTC nasal decongestants, published in the Aug. 23 Federal Register. A warning that overuse of phenylephrine HCl 1% products may cause a rebound of symptoms, which was originally proposed in the nasal decongestant tentative final monograph in January 1985, is extended to all topical nasal decongestants in the final monograph.