FDA Issues Guidance on Labeling of Acetaminophen, Aspirin-Containing Drug Products

The Food and Drug Administration on Jan. 10 released two guidance documents on labeling of over-the-counter drug products. Guidance on over-the-counter acetaminophen-containing drug products (here) says FDA “does not intend to take action against the marketing of single- and combination-ingredient, acetaminophen-containing,” over-the-counter “drug products bearing a warning as described in the guidance alerting consumers that the use of acetaminophen may cause severe skin reactions,” it said (here). A draft guidance document on the recommended statement for over-the-counter products that contain aspirin (here) encourages “drug manufacturers, packagers, and labelers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 ... secondary prevention” of heart-related events, FDA said (here).