FDA Warns About Misleading NyQuil Labels Promoting Vitamin C Benefits

Labels on some bottles of the popular over-the-counter cold remedies Vicks NyQuil and DayQuil contain false and misleading claims about the health benefits of vitamin C contained in the products, the Food and Drug Administration said.


The FDA has sent a warning label to Procter and Gamble Co., the maker of the products, to point out that agency rules forbid combining vitamin C and other active ingredients in the over-the-counter products.

NyQuil and DayQuil bottles also have run afoul of the FDA because they list vitamin C as an inactive ingredient, officials said.

“Because the vitamin C in these products is an active drug ingredient, it is therefore both false and misleading to state that it is an inactive ingredient in these drug products,” the FDA wrote in a letter sent to the company, according to a Reuters news report.

The labels on DayQuil Plus Vitamin C say the products contain more than 150 percent of the recommended daily value of vitamin C. The FDA said listing vitamin C as both a dietary ingredient and an inactive ingredient in the labeling is misleading and confusing to consumers.

Procter and Gamble said the way vitamin C is promoted on the NyQuil and DayQuil labels is designed to distinguish the benefits provided by the products’ active ingredients compared to the dietary supplement use of vitamin C.

The company issued a statement saying it is “marketing within the FDA regulations and will work with the FDA to resolve the concern together.” The FDA asked Procter & Gamble to respond within 15 days to say how the company plans to address the concerns about labeling claims.

Bayer Products Also Cited for Labeling Claims

This is not the first time the FDA has warned drug manufacturers about labeling claims of benefits from dietary supplements. In October 2008, the agency said some over-the-counter Bayer aspirin products were being illegally marketed because they contained dietary supplements that had not been proven effective. The pain relievers involved in that FDA action were Bayer Aspirin with Heart Advantage and Bayer Women’s Low Dose Aspirin + Calcium.

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