The Food and Drug Administration (FDA) is proposing the removal of a common ingredient, oral phenylephrine, found in most over-the-counter cold medicines for being ineffective as a nasal decongestant in liquid or pill form. However, it is still considered effective in nasal sprays.
The FDA’s proposal is based on a review of available data and is consistent with the advice of an advisory committee that concluded oral phenylephrine is not effective as a nasal decongestant.
The big picture: Currently, oral phenylephrine is widely used in products like Tylenol Cold and Flu, Mucinex, and Dayquil. The presence of phenylephrine does not affect how the other active ingredients work.
- The proposal is open to public comments, and if the FDA makes a final decision, products containing oral phenylephrine would have to be removed from shelves, giving manufacturers time to either reformulate the drugs or remove them from the market.
- The move comes after an FDA advisory panel unanimously agreed that there was no scientific evidence to support the claim that phenylephrine was an effective decongestant at standard or higher doses.
