FDA Warning About Children and OTC Cold Medicines

Jamie Sheller

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Parents are warned about the risks of giving OTC cough and cold medications to young children. The FDA says that parents should not give such medicines to children younger than two years old. According to the FDA's Public Health Advisory, there are serious questions about whether the risks of these products outweigh the benefits in young children. Earlier this year, a group of pediatricians and public health authorities sought to halt marketing of OTC cough and cold medicines to children younger than six, due to uncertainty about safety and efficacy of the products. Three infant deaths had been linked to three ingredients commonly used in OTC cough and cold medicines. The three ingredients are pseudoephedrine, dextromethorphan and acetaminophen. On October 18, the FDA will hold an advisory panel meeting, where findings will be presented about the safety and efficacy of specific cough and cold medication ingredients.

For more information on this subject matter, please refer to the section on Drugs, Medical Devices, and Implants.