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Revised Product Labels for Pediatric Over-the-Counter Cough and Cold Medicines

October 7, 2008, the Consumer Healthcare Products Association announced that the leading manufacturers of pediatric over-the-counter cough and cold medicines would voluntarily modify the labels on these products to state that they should not be used in children aged <4 years.*

Previous product labels stated that these medicines should not be used in children aged <2 years. Existing products with these labels will not be removed immediately from store shelves but are expected to be replaced eventually with newly labeled products. Health-care providers should be aware of the new labels and should alert parents and caregivers to this change.

Serious injuries and deaths have been reported among infants and children who received over-the-counter cough and cold medicines, but most adverse events resulted from overdoses or unsupervised ingestions (1--3). To promote child safety, the Food and Drug Administration and CDC have developed materials to educate parents, health-care providers, and consumers about how and when these products can be used safely. Additional information is available at http://www.fda.gov/bbs/topics/news/2008/new01899.html.

References

  1. Food and Drug Administration. Cold, cough, allergy, bronchodilator, antiasthmatic drug products for over-the-counter human use. Memorandum from the Nonprescription Drug Advisory Committee meeting, October 18--19, 2007. Available at http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4323b1-02-fda.pdf.
  2. CDC. Infant deaths associated with cough and cold medications---two states, 2005. MMWR 2007;56:1--4.
  3. Schaefer MK, Shehab N, Cohen AL, Budnitz DS. Adverse events from cough and cold medications in children. Pediatrics 2008;121:783--7.

* Additional information available at http://www.chpa-info.org/10_07_08_pedcc.aspx.

Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.


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Date last reviewed: 10/29/2008

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