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FDA officials said an agency review of the available data found oral phenylephrine is not effective as a nasal decongestant when taken in liquid or pill form, more than a year after an agency ...
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 ...
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 ...
In a preemptive move, CVS stopped selling products with phenylephrine last year after an FDA advisory committee declared that it was ineffective. Other major pharmacies, including Walgreens and ...
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 ...
Like many other over-the-counter ingredients, phenylephrine was essentially grandfathered into approval during a sweeping FDA review begun in 1972. It has been sold in various forms for more than ...
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.
Do over-the-counter decongestants like Sudafed PE work? Doctors have said oral phenylephrine is ineffective to relieve nasal congestion. An FDA panel will reevaluate the evidence.