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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
- 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.
- CDC. Infant deaths associated with cough and cold medications---two states, 2005. MMWR 2007;56:1--4.
- 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.
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Date last reviewed: 10/29/2008
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