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On Thursday, the FDA proposed removing oral phenylephrine from the list of approved active ingredients for over-the-counter (OTC) nasal decongestants, citing concerns over its effectiveness. After ...
The U.S. Food and Drug Administration (FDA) announced that it plans to ban products containing phenylephrine, an ingredient found in many over-the-counter (OTC) oral cold and flu medications.
The unanimous vote, which specifically declared oral formulations of phenylephrine ineffective, is expected to disrupt the market for OTC cold and allergy remedies, where consumers largely prefer ...
The FDA advisory committee’s decision last year was nonbinding — meaning the FDA itself makes the final call on whether oral phenylephrine is considered effective and whether it needs to be ...
The FDA said that the panel's recommendation is not final, but would "consider the input of this advisory committee, and the evidence, before taking any action on the status of oral phenylephrine."
The stakes are high, experts say, because a committee vote declaring phenylephrine ineffective as an oral decongestant could push the FDA to revoke the drug’s over-the-counter designation as ...
The 2010 Johnson & Johnson children's product recall involved 43 over-the-counter children's medicines announced by McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, on April 30, 2010. Medications in the recall included liquid versions of Tylenol, Tylenol Plus, Motrin, Zyrtec, and Benadryl. The products were recalled after it was ...
Phenylephrine, a popular ingredient in many over-the-counter allergy and cold medicines, is ineffective in tablet form, an independent advisory committee to the US Food and Drug Administration ...