Health literacy assessment of labeling of pediatric nonprescription medications: examination of characteristics that may impair parent understanding.

OBJECTIVE: Poor quality and variability of medication labeling have been cited as key contributors to medication misuse. We assessed the format and content of labels and materials packaged with common pediatric liquid nonprescription medications.

METHODS: Descriptive study. A total of 200 top-selling pediatric oral liquid nonprescription medications (during the 52 weeks ending October 30, 2009) categorized as analgesic, cough/cold, allergy, and gastrointestinal products, with dosing information for children <12 years (representing 99% of U.S. market for these products) were reviewed. The principal display panel (PDP) and FDA Drug Facts panel (side panel) of each bottle, and associated box, if present, were independently examined by 2 abstractors. Outcome measures were content and format of active ingredient information and dosing instructions of the principal display panel and Drug Facts panel.

RESULTS: Although almost all products listed active ingredients on the Drug Facts panel (side panel), nearly 1 in 5 (37 [18.5%]) did not list active ingredients on the PDP. When present, mean (SD) font size for PDP active ingredients was 10.7 (5.0), smaller than product brand name (32.1 [15.0]) and flavor (13.1 [4.8]); P < .001. Most products included directions in chart form (bottle: 167 [83.5%], box: 148 [96.1%], P < .001); mean (SD) font size: 5.5 (0.9; bottle), 6.5 (0.5; box), P < .001. Few products expressed dosing instructions in pictographic form: 4 (2.6%) boxes and 0 bottles. Nearly all products included the Food and Drug Administration-mandated sections.

CONCLUSIONS: The format and content of labels for nonprescription pediatric liquid medications could be improved to facilitate parent understanding of key medication information, including active ingredient information and dosing instructions.