A stroll down your local pharmacy OTC drug aisle will highlight the numerous OTC drug products available for adults and children. However, for children younger than 12 years of age, it is best not to use commonly advertised OTC cough and cold drug products. OTC drugs regulated differently than Rx drugsFDA regulation of OTC drug products differs from prescription drug regulation . Active ingredients in OTC drug products are evaluated and approved by therapeutic category, such as the cough and cold therapeutic category. The FDA agreed , and this remains the current status of pediatric age labeling for OTC cough and cold products.
Source: CNN November 25, 2016 09:44 UTC