The FDA has sent a warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C (acetaminophen, dextromethorphan HBr, phenylephrine HCl, vitamin C) and Vicks NyQuil Plus Vitamin C (acetaminophen, doxylamine succinate, dextromethorphan HBr, vitamin C) for the relief of cold and flu symptoms are illegally marketed. Under its over-the-counter (OTC) monograph system, the FDA allows some OTC drugs to be marketed without agency approval. Such drugs must comply with applicable monographs. Products containing combinations of the active ingredients acetaminophen, dextromethorphan HBr, phenylephrine HCl, and doxylamine succinate, and intended for the treatment of cold and flu symptoms, are subject to the final monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for OTC Human Use. That final monograph does not allow for the combination of vitamin C with any of the other active ingredients.
Because Vicks DayQuil Plus Vitamin C and Vicks NyQuil Plus Vitamin C do not comply with the final monograph for OTC Cold-Cough Drug Products, they are not recognized as safe and effective. While the vitamin C in these products could be marketed separately as a dietary supplement, when drug and dietary ingredients are combined into a single dosage form, the combination becomes a “drug” and must be evaluated and approved under the FDA’s new drug approval process to be legally marketed.
For more information visit www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm188361.htm.