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FDA
Posted: Mon, Jan 21 2008, 9:27 am EST
Post subject: OTC cough and cold products not be used for kids under 2 years of age
Public Health Advisory
Nonprescription Cough and Cold Medicine Use in Children
FDA Recommends that Over-the-Counter (OTC) Cough and Cold Products not be used for Infants and Children under 2 Years of Age
FDA has completed its review of information about the safety of over-the-counter (OTC) cough and cold medicines in infants and children under 2 years of age. FDA is recommending that these drugs not be used to treat infants and children under 2 years of age because serious and potentially life-threatening side effects can occur.
FDA’s recommendation is based on both the review of the information we received about serious side effects in children and the discussion and recommendations made at the October 18–19, 2007, public advisory committee meeting at which this issue was discussed. FDA strongly supports the actions taken by many pharmaceutical manufacturers to voluntarily withdraw cough and cold medicines that were being sold for use in this age group.
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http://www.fda.gov/cder/drug/advisory/cough_cold_2008.htm