Understanding the SAFE USE of
Pediatric Cough and Cold Medicines
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| INFANT PRODUCTS Wyeth Consumer Healthcare has voluntarily removed its “infant” cough and cold products from the market to help reduce dosing errors and overdoses in children under age 2. This age group of children is the most vulnerable to overdose and misuse of cough and cold medicines. We feel that this action helps clarify appropriate usage for medicines in this product category. In addition, Wyeth Consumer Healthcare is in the process of voluntarily changing the labeling on its other cough and cold product labels to further help reduce dosing errors and overdoses. Specifically, the new labeling will advise doctors and parents “Do not use in children under two years of age.” FDA ADVISORY COMMITTEE MEETINGRecently, the Food and Drug Administration (FDA) convened a meeting of experts and advisors on pediatric cough and cold medicines to discuss the safety and effectiveness of over the counter cough and cold products for children. You may have seen or heard in the news some conclusions regarding recommendations provided by the Advisory Committee. It is important to note that the FDA has not issued a final ruling on this matter. The FDA will consider the committee’s recommendations and may issue changes to the regulations on cough and cold products. Wyeth Consumer Healthcare appreciates the input of the Advisory Committee and will comply with the final FDA decisions when they are issued. It is unclear when the FDA decisions will be made.
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IMPORTANT INFORMATION FOR PARENTS TO REMEMBER For children 2 to under 6 years of age, we recommend that you ask your health care professional before giving cough and cold products to your children. It is important to remember that these products can be used safely when taken as directed. Wyeth Consumer Healthcare will continue to update its websites with current information once the FDA has announced any new regulations for children’s cough and cold medicines. If you have questions, please call your health care professional or Wyeth Consumer Healthcare at 1-800-762-4675, Weekdays from 9AM to 5PM EST. |
