Improved Label and Liver Warning for Nonprescription Acetaminophen Products

To compare consumer preferences for a revised and current acetaminophen over-the-counter "Drug Facts" labels (ODFL) on warnings and self-reported correct intended action following signs of overdose.

Adults visiting a community center were randomly assigned to revised or current ODFLs using previously reported label comprehension methodology.

Participant (N = 110) ratings for both ODFLs were comparable for ease of finding and understanding information. In response to an emergent overdose scenario, the proportion reporting the correct intended action using the revised ODFL was significantly greater than the proportion using the current ODFL (91% [97.5% CI, 0.82-0.99] vs. 76% [97.5% CI, 0.64-0.89]). In side-by-side comparisons, the revised ODFL was superior for overall consumer preference, usefulness for first-time use, and better overdose-related directions. A revised bottle cap statement also outperformed the current statement used on brand acetaminophen.

Findings support revision of acetaminophen ODFLs to improve liver damage warnings and to optimize labeling likely to be useful in prevention of and response to overdose.