Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
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The Food and Drug Administration (FDA) is announcing the availability on its website of the proposed administrative order (proposed order) (OTC000036) entitled "Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use." This proposed order, if finalized, will amend Final Administrative Order OTC000026, to remove orally administered phenylephrine hydrochloride and phenylephrine bitartrate in an effervescent dosage as nasal decongestant active ingredients because they are not effective.
Abstract as published in the Federal Register.
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