(NEW YORK) -- The FDA is requiring that label warnings on prescription cough medication benzonatate (Tessalon) be changed to caution parents to keep it out of reach of children, reports MedPage Today.
"Benzonatate should be kept in a child-resistant container and stored out of reach of children," said Carol Holquist, director of the FDA's Division of Medication Error Prevention and Analysis.
There have been reports of 31 overdoses and five toddler deaths related to the gelcaps, which look like candy. Data included in the reports prompted action by the FDA.
The product, approved in 1958 for cough treatment in patients 10 and older, will remain on the market after the new label information is added.
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