FDA Issues Warning on Prescription Cough Medication Benzonatate (Tessalon) After Child Deaths


Benzonatate is a prescription cough suppressant used to treat cough due to the common cold, bronchitis, pneumonia, or other lung infections. It is sold in the United States under the brand name Tessalon Perles (gelcaps) or Tessalon Capsules.

Recently, the FDA reviewed reports on 31 overdoses of Tessalon, including the deaths of five toddlers. The outcome of the review was a stronger warning on the drug's label about risks of accidental ingestion resulting in overdose and death in children younger than 10.

The FDA indicated that Tessalon is sold in colored gelcaps with a "candy-like" appearance.

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