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FDA Issues Warning Letter on Nyquil

FDA Issues Warning Letter on Nyquil

The FDA has accused Procter & Gamble (P&G) of submitting one ingredient list for Nyquil to the agency and using a different one for the over-the-counter product’s physical labeling.

In a March 14 warning letter to the company, the agency threatened that a failure to adequately address the matter “may result in legal action,” including the possibility of seizure and injunction.

The active ingredients described under the Drug Facts section of the labeling and Principal Display Panel image for Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion are acetaminophen, dextromethorphan hbr, doxylamine succinate and phenylephrine, while the active ingredients submitted to the FDA included in the electronic listing file are acetaminophen, dextromethorphan hbr, phenylephrine and guaifenesin, the agency said.

The active ingredient doxylamine, an antihistamine and sleep aid, is missing from the electronic listing file and guaifenesin listed instead. Guaifenesin is used to help clear phlegm from the chest that results from a cold or flu.

The drug is now considered misbranded because of the contradictory information for Nyquil, the agency said.

March 23, 2023


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