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FHCP Statement on September 11-12 FDA Meeting of the Nonprescription Drugs Advisory Committee (Phenylephrine)
Created on 9/22/2023 9:41:19 AM

(Ottawa) September 18, 2023 — FHCP and our members have closely monitored the independent advice and recommendations of the US FDA’s Nonprescription Drugs Advisory Committee regarding the efficacy of the oral decongestant ingredient phenylephrine.  

In previous reviews, FDA has consistently classified phenylephrine as Generally Recognized as Safe and Effective (GRASE) and neither the FDA nor the committee raised concerns about safety issues with the use of oral phenylephrine at the recommended dose.

In Canada, phenylephrine is approved for use as an oral decongestant. FHCP and its members will work with Health Canada to ensure self-care options continue to be readily available for Canadians during the upcoming cold and flu season.