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Business · 23/02/1995Updated: 10/18/2026 · 1 min read

FDA Proposes Changes to Monograph for Over-the-Counter Cold, Cough, and Allergy Medications

Summary

The Food and Drug Administration (FDA) is proposing to update the guidelines for over-the-counter cold, cough, allergy, bronchodilator, and antiasthmatic combination medications, which would include diphenhydramine citrate and diphenhydramine hydrochloride, following recent amendments to the final monograph for OTC cough relief medications and previous inclusions in the final monograph for OTC antihistamine medications.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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