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Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular-Related Imagery; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Recommended Statement for Over-the-Counter Aspirin-Containi...

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular-Related Imagery.'' The guidance is intended to promote the safe use of nonprescription (also referred to as over-the- counter or OTC) aspirin drug products by encouraging drug manufacturers, packagers, and labelers marketing aspirin drug products with cardiovascular-related imagery to include a statement that reminds consumers to talk to their health care provider before using aspirin for their heart.

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82 FR 51631

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“Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular-Related Imagery; Guidance for Industry; Availability,” thefederalregister.org (November 7, 2017), https://thefederalregister.org/documents/2017-24192/recommended-statement-for-over-the-counter-aspirin-containing-drug-products-labeled-with-cardiovascular-related-imagery-.