FDA is warning the public that accidental ingestion of benzonatate by children under the age of 10 years can result in death from overdose. Benzonatate is a prescription drug approved for relief of cough in patients over 10 years of age. The safety and effectiveness of benzonatate in children under 10 years of age have not been established. Benzonatate is sold under the brand name Tessalon and is also sold in generic preparations.

All accidental ingestions reported to FDA to date occurred in children less than 10 years of age. Overdose with benzonatate in children less than 2 years of age has been reported following accidental ingestion of as few as 1 or 2 capsules. Individuals who experience overdose of benzonatate may exhibit restlessness, tremors, convulsions, coma, and cardiac arrest. Signs and symptoms of overdose can occur rapidly after ingestion (within 15-20 minutes). Deaths in children have been reported within hours of the accidental ingestion.

Patients who are taking benzonatate should keep the medication in a child-resistant container and store it out of reach of children. If a child accidentally ingests benzonatate, seek medical attention immediately.

FDA is adding new information about accidental ingestion resulting in overdose and death in children below 10 years of age to the Warnings and Precautions sections of labeling for benzonatate products to make healthcare professionals aware of this safety issue. FDA encourages healthcare professionals to talk with their patients about this risk.