Navigation Links
FDA: Procter & Gamble Unlawfully Marketing Two Vicks Cold and Flu Medicines Containing Vitamin C

SILVER SPRING, Md., Oct. 30 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today sent a warning letter to Procter & Gamble notifying 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.

(Logo: )

Both of the over-the-counter (OTC) medicines, which contain vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms. The FDA took the action against 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 are insufficient data to show that vitamin C is safe and effective in preventing or treating the common cold.

Under its OTC monograph system, the FDA allows some OTC drugs to be marketed without agency approval. Such drugs must comply with applicable monographs, which are regulations that set requirements for the drugs' labeling, formulations and indications. The two Vicks products do not comply with the applicable FDA monograph and must first be evaluated and approved under the FDA's new drug approval process to be legally marketed.

The FDA's position on the regulatory status of OTC drug products that combine drug ingredients with dietary ingredients in a single dosage form has been described in previous warning letters issued in 2001 and 2008. The agency's position on the marketing of vitamin C for preventing or treating the common cold also has been stated in a number of previous warning letters.

(Editor's note: The warning letter sent to Procter & Gamble today concerns the same products as the letter mistakenly posted on the FDA Web site on Oct. 14, 2009, due to a computer error.)

For more information

FDA Warning Letter to Procter & Gamble

FDA Drug Safety Initiative

Media Inquiries: Christopher Kelly, 301-796-4676,

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

SOURCE U.S. Food and Drug Administration
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Procter & Gamble Pharmaceuticals Launches Asacol(R) HD (mesalamine) Delayed-Release Tablets
2. Nastech Reacquires Teriparatide (Parathyroid Hormone; PTH1-34) Nasal Spray from Procter & Gamble
3. Warner Chilcott Completes Acquisition of P&Gs Global Branded Prescription Pharmaceuticals Business
4. Neuro Kinetics & Military Researchers in Push To Improve Diagnosis & Treatment of Combat Brain Injuries
5. CVS Caremarks MinuteClinic and Allina Hospitals & Clinics Form Strategic Partnership
6. Reportlinker Adds Medical Devices & Equipment in India (2009)
7. Ikaria Receives Award for Excellence by New Jersey Business & Industry Association
8. Laureate Pharma Announces Signing New Biopharmaceutical Development & Manufacturing Agreement
9. Lifesciences IT Spending to Experience Mature Growth Rates Despite Economic Slowdown, Declares Frost & Sullivan
10. MedImmune to Present Data on RSV and Influenza at 2009 American Academy of Pediatrics National Conference & Exhibition
11. Palomar to Commercialize FDA Cleared Over-The-Counter Home Use Wrinkle Treatment Laser Device Without Johnson & Johnson
Post Your Comments:
(Date:11/25/2015)... LYON , Frankreich, November 25, 2015 ... hat heute bekanntgegeben, dass sie eine Lizenz für das ... Inserm, Poxel, CNRS, UCBL und ENS-Lyon innehaben, an Enyo ... 2009 von FUI AAP8 ins Leben gerufenen und von ... NATHEB-Programms wurde FXR als ein Behandlungsziel für HBV identifiziert, ...
(Date:11/24/2015)... Nov. 24, 2015  Natera, Inc. (Nasdaq: ... genetic testing and the analysis of circulating ... present at the 27 th  Annual Piper ... 2015 at 1:00 p.m. ET.  Matthew Rabinowitz, Ph.D., CEO of ... business activities and financial outlook. ...
(Date:11/24/2015)... , 24. November 2015 Avery ... Pacemaker Systems, ist erfreut, die Berufung von ... bekannt geben zu können. ... --> Foto - ... (Schweden). Von 1984-1986 war er Fellow des ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... Dr. John Pierce, Medical Director at the Ageless ... treatment with the Capillus272™ Pro laser therapy cap. FDA cleared for safety and efficacy, ... without the need for surgery, prescription pills, or topical foams. , “Capillus272™ Pro ...
(Date:11/25/2015)... ... November 25, 2015 , ... Lakeview Health, ... country to celebrate their sobriety and show through pictures what a positive difference ... photos this Thanksgiving with the hashtag #FacesOfGratitude on their Facebook, Twitter, and Instagram ...
(Date:11/25/2015)... , ... November 25, 2015 , ... On November 23rd ... Tri Lite’s personal heating products business. Cozy Products explains what this means ... that fit in well with the Cozy Products business model: to sell personal heaters ...
(Date:11/25/2015)... MI (PRWEB) , ... November 25, 2015 , ... In ... Presence Resurrection Medical Center (RMC) in Chicago, IL, UV Angel is evaluating the efficacy ... medical and surgical intensive care units (totaling 30 beds) from May 2014 through October ...
(Date:11/25/2015)... PA (PRWEB) , ... November 25, 2015 , ... ... treat my cancer, I found that regular bras were incredibly uncomfortable," said an ... developed this specialized bra." , She developed the patent-pending RECOVERY BRA for added ...
Breaking Medicine News(10 mins):