Guide on OTC Aspirin Labels Using Heart Imagery

FDA has posted a guidance on “Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery.” The document applies to single-ingredient aspirin, buffered aspirin, and aspirin in combination with an antacid, labeled with cardiovascular-related imagery marketed under the agency’s Tentative Final Monograph for Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for OTC Human Use.

FDA says it is aware that some OTC aspirin drug products are marketed with cardiovascular-related images (heart symbols) that imply the products are intended for use in preventing cardiovascular events. “Secondary prevention of cardiovascular events is permitted as an indication for aspirin in professional labeling,” the guidance notes, recommending that such products include a statement that reminds consumers to talk to their doctor or other healthcare provider before using aspirin as a secondary prevention.