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FDA Releases Recommendations Regarding Use of Over-the-Counter Cough and Cold Products

Press release: “The U.S. Food and Drug Administration today issued a Public Health Advisory for parents and caregivers, recommending that over-the-counter (OTC) cough and cold products should not be used to treat infants and children less than 2 years of age because serious and potentially life-threatening side effects can occur from such use. OTC cough and cold products include decongestants, expectorants, antihistamines, and antitussives (cough suppressants) for the treatment of colds. There are a wide variety of rare, serious adverse events reported with cough and cold products. They include death, convulsions, rapid heart rates, and decreased levels of consciousness.”

  • Public Health Advisory: Nonprescription Cough and Cold Medicine Use in Children
  • Questions and Answers for Consumers
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