The FDA is recommending that over-the-counter (OTC) cough and cold medicines no longer be used to treat children <2 years of age due to the risk of serious and potentially life-threatening side effects. This recommendation is based on both a review of information concerning serious side effects in children and the discussion and recommendations made at a public advisory committee meeting in October 2007. The FDA continues to review safety information regarding OTC cough and cold medicines in children 2-11 years of age and expects to publicly issue a recommendation in the near future.

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