AAP News Vol. 2 No. 3 March 1986, p. 1
© 1986 American Academy of Pediatrics
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FDA mandates Reye Syndrome warning labels for aspirin

The U.S. Food and Drug Administration (FDA) recently ruled that starting June 5 all non-prescription aspirin products and medications containing aspirin must be labeled with a warning about Reye Syndrome.

The FDA announced that all aspirin products — not just those exclusively for children — must display the warning, a decision strongly supported by the Academy. The rule will cover rectal products as well as oral ones.

However, the FDA rejected recommendations from the Academy and the American Medical Association for more explicit wording in the warning.