Oral Phenylephrine Not Effective: FDA Proposes Removal

USFDA is proposing to remove oral phenylephrine as an active ingredient in over-the-counter (OTC) drug products for nasal congestion. An review determined that oral phenylephrine is not effective for relief of nasal congestion.

As this is a proposed order, companies may continue to market OTC monograph drug products containing oral phenylephrine. FDA is seeking public comments on the order and after considering the comments, FDA will conclude the final order. If FDA concludes oral phenylephrine is not effective as a nasal decongestant, drug products thereafter could no longer contain oral phenylephrine.

Oral phenylephrine is widely used as a nasal decongestant active ingredient in many OTC monograph drug products. Sudafex PE, Tylenol Sinus+Headache are some of the popular could and cold medications with oral phenylephrine. The FDA’s action is only related to orally administered phenylephrine and not the nasal spray form

Links:

FDA Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant