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Using OTC Cough and Cold Products in Children

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On Oct. 8, 2008, the Food and Drug Administration (FDA) released a statement that supports recent voluntary actions by many drug manufacturers regarding the use of nonprescription, over-the-counter (OTC) cough and cold products in children.

The voluntary actions announced by the Consumer Healthcare Products Association (CHPA) are intended to help prevent and reduce the misuse of these products in children and to better inform consumers about their safe and effective use. CHPA represents most of the manufacturers of these products.

Members of CHPA have volunteered to modify the product labels of OTC cough and cold medicines to state "do not use" in children under 4 years of age. (Many of the products currently state "do not use" in children under 2 years of age.) Additionally, the manufacturers are introducing new child-resistant packaging and new measuring devices for use with the products.

CHPA's voluntary actions will not affect the availability of the medicines, but will result in a transition period where the instructions for using some OTC cough and cold medicines in children will be different from others. Some product instructions will state "do not use" in children under 4 years of age, while others will instruct not to use in children under 2 years of age.

FDA does not typically request that OTC products with previous labeling be removed from the shelves during a voluntary label change such as this one. The agency recommends following the dosage instructions and warnings on the label that accompanies the medication if you have or buy a product that does not have the voluntarily modified labeling.

Recent FDA Actions

  • FDA has held two public meetings over the past year on the safe use of nonprescription OTC cough and cold medicines in children. The most recent meeting on Oct. 2, 2008, focused on labeling of these products.
  • FDA issued a nationwide Public Health Advisory in January 2008 recommending that these products not be used in children under the age of 2 because of the risk of serious and potentially life-threatening side effects.
  • FDA continues to reach out to other public health agencies, consumer and patient groups, drug manufacturers, CHPA, and the scientific community. As it obtains more up-to-date information and scientific data about the safety and effectiveness of these products in children, FDA can take the appropriate regulatory steps moving forward.
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