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The U.S. Food and Drug Administration said Friday that it had sent a warning letter to Procter & Gamble, telling the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient.
Both of the over-the-counter medicines, which contain vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu. The FDA said it cited the Cincinnati-based company to clarify that these single dosage form combinations of drug ingredients and dietary ingredients legally cannot be marketed because they have not been proven safe and effective, and because the agency previously determined that there is insufficient evidence to show that vitamin C is safe and effective in preventing or treating the common cold.
The FDA said the two products must first be evaluated and approved under the agency's new drug approval process to be legally marketed.