FDA Okays Heart Health Imagery on OTC Aspirin Products With Appropriate Written Warning

The FDA will not penalize OTC aspirin manufacturers for including cardiovascular-related imagery on labels if they also include approved language.

But because of potential side effects tied to long-term aspirin therapy, any manufacturer using such imagery, such as graphics depicting hearts, electrocardiography or stethoscopes should also include information reminding consumers to consult with healthcare providers before using the product for secondary prevention of cardiovascular events, according to the FDA.

Any such imagery should be accompanied by the statement "Talk to your doctor or other healthcare provider before using this product for your heart" in at least 6-point type. The recommended statement was updated from a January draft to make it more consumer-friendly.