This guidance applies to single-ingredient aspirin, buffered aspirin, and aspirin in combination with an antacid, labeled with cardiovascular related imagery marketed under the Tentative Final Monograph (TFM) for Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) Drug Products for OTC Human Use (53 FR 46204, November 16, 1988). FDA is aware that some over-the-counter (OTC) aspirin drug products are marketed with cardiovascular related images, such as heart symbols, which suggest or imply that the products are intended for use in the prevention of cardiovascular events. Secondary prevention of cardiovascular events is permitted as an indication for aspirin in professional labeling (21 CFR 343.80). This guidance is intended to promote the safe use of 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 healthcare provider before using aspirin for the professional indication of secondary prevention of cardiovascular events.


Posted on the FDA website on 10 January 2017