Objective: To test the effect of current versus 2 experimental label formats on information processing among current and potential over-the-counter (OTC) users.
Methods: A cross-sectional survey was conducted in a cohort of adults across a metropolitan community, Houston, Texas. Three labels were designed. We placed a chunk of like information together (uses, direction, other information). Label A (control) followed the format of the existing FDA Drug Facts panel format for an antiallergy medication, label B had warnings placed before, while label C had warnings placed after the chunk. The 2 label designs were compared using the information-processing constructs derived from the OTC Label Evaluation Process Model (LEPM).
Results: A multivariate analysis of covariance and Dunnett's test revealed that the mean scores for constructs of OTC LEPM were significantly better for label C compared to the control and label B ( P < .0001).
Conclusion: Our label format improved information processing among consumers but only when warning placement was placed at the end in the Drug Facts panel, giving an opportunity for the FDA to consider revising the format of the OTC Drug Facts panel, to improve patient understanding and reciprocally enhance patient safety.
Keywords: information processing; label format; over-the-counter; patient understanding.