P&G labeling missteps garner warning

Procter & Gamble has been cited for the illegal marketing of combinations of dietary ingredients and drugs.

P&G products Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C lack proof of safety and efficacy, the regulator says, citing lack of scientific evidence linking vitamin C to the prevention and treatment of colds.

In addition, labeling on the two over-the-counter medicines incorrectly identifies acetaminophen, detromethorphan HBr, and phenylephrine HCl or doxylamine succinate as "other ingredients" as well as active drug ingredients; vitamin C was identified as both an inactive and active ingredient.

Corrective steps response deadline under the tougher FDA: within 15 days of the October 29, 2009, warning latter date.

- here's the article
- see the warning letter


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