OBJECTIVE: Hispanic consumers who do not speak English may have difficulty in interpreting information provided on Over-the-Counter (OTC) medication labels. This study developed bilingual Product Information Labels (PILs) for OTCs and compared them to existing OTC labels. METHODS: The study had a randomized-within subjects design. Three hundred and thirty-six consumers, from pharmacy stores in Houston, TX, participated in the study. Participants were selected randomly and they viewed, in a random order, each label format for acetaminophen, ibuprofen and aspirin. Each label was followed by a questionnaire for participants. Consumers were divided into three language categories, namely, only English-speaking, only Spanish-speaking and bilinguals. Variables measured on the questionnaire were ease of use, product knowledge, attitude towards product label, product evaluation and purchase intention. Data were coded and analyzed using the SAS statistical package (Version 9.0). Descriptive and comparative statistics were computed for each variable as well as for all label formats. RESULTS: Means obtained for PILs were significantly different from those obtained for old and new formats (p<0.05) for all consumer categories. A majority of participants were very certain that they understood the information on PILs (68.15%) and were very satisfied (74.11%) that they understood this information shown on the package label. Moreover, about 85% of participants who used the Spanish language information on PILs found it very useful. CONCLUSIONS: Bilingual PILs, as compared existing label formats, are an effective means of providing information to all Hispanic consumers. These results may help the FDA in developing policies to enhance the safety of OTC medication used for the large Hispanic population in the USA.