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To assess the rate of pediatric adverse events associated with over-the-counter (OTC) cough and cold medications in the U.S., investigators analyzed data from the Pediatric Cough and Cold Safety Surveillance System for patients <12 years of age reported to have at least one adverse event associated with any of the following pharmaceuticals: brompheniramine, chlorpheniramine, dextromethorphan, diphenhydramine, doxylamine, guaifenesin, pseudoephedrine, and phenylephrine.
Of 3251 adverse events reported from 2009 to 2014, 60% occurred in children <4 years of age. The most common exposures were accidental unsupervised ingestions (67%) and medication dosing errors (13%). Almost all accidental unsupervised ingestions were self-administered, with 9…