The Federal Drug Administration is warning the public, specifically parents of young children, that accidential ingestion of benzonatate (Tessalon) by children under the age of 10 years can result in death from overdose.

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. Benzonatate may be attractive to children because of the drug's appearance (it is a round-shaped liquid-filled gelatin capsule).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. 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.Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by submitting the report online at

www.fda.gov/MedWatch/report.htm; calling 1-800-332-1088 to request a reporting form, then completing and returning form to the address on the pre-addressed form; or submitting a report by fax to 1-800-FDA-0178.