November 13, 2024 – The U.S. Meals and Drug Administration introduced that it’s proposing to take away oral phenylephrine as an energetic ingredient that can be utilized in over-the-counter monograph merchandise for the momentary reduction of nasal congestion after an company assessment of accessible information discovered that oral phenylephrine just isn’t efficient for this use. At present, oral phenylephrine is extensively used as an energetic ingredient for nasal decongestants in lots of OTC monograph medicine. For now, firms can proceed to market over-the-counter monograph medicine containing oral phenylephrine for nasal congestion reduction. This can be a recommended order. Solely a ultimate order impacts which merchandise could be dropped at market. The proposed order relies on effectiveness considerations, not security considerations.

In accordance with the FDA, you will need to word that some merchandise solely comprise oral phenylephrine as the only energetic ingredient. Others comprise oral phenylephrine and one other energetic ingredient (e.g., acetaminophen or dextromethorphan), and the presence of oral phenylephrine in these medicine doesn’t have an effect on how different energetic substances work to deal with the signs they’re supposed to deal with.

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