Safety Alerts & Recalls

What does this mean?

This recommendation follows a number of communications made by the FDA and manufacturers on this issue. These medications should not be used in patients under 2 years old unless under the direction and supervision of a doctor.

FDA recommendation regarding use in children

The FDA today recommended that over-the-counter (OTC) cough and cold medicines should not be used in children under 2 years of age due to the potential for serious and potentially life-threatening side effects. This recommendation was based on reports of serious side effects made to the FDA and a public advisory committee meeting held in October last year. According to today's announcement, the FDA is still conducting a review regarding the safety of these medicines for children 2 through 11 years of age.

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Source: FDA
Publication Date: 2008-01-17
Last Updated: 2009-12-06

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