FDA Proposes Amendment to Monograph for Over-the-Counter Nasal Decongestant Drug Products

Summary

The Food and Drug Administration (FDA) is proposing to add phenylephrine bitartrate to the final monograph for over-the-counter nasal decongestant drug products, which are used to relieve nasal congestion due to a cold, hay fever, or other upper respiratory allergies, when used in an effervescent tablet.