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Boxed Warning Audio (En español)

Also known as: Black Box Warning, Black Label Warning

The strongest form of warning required by the Food and Drug Administration (FDA) for prescription drug labeling. A boxed warning alerts health care providers and consumers to increased risk of serious adverse reactions associated with use of a drug or to restrictions on use of a drug. The boxed warning is presented in a box surrounded by a black border and is placed on the drug label and any package inserts or promotional materials intended for the prescriber or patient.

See Related Term(s): Food and Drug Administration, Package Insert

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