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Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery; Draft Guidance for Industry; Availability

Samenvatting

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery."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.