Labelling Compliance of Over-the-Counter Medicines With National Regulations

Labels on over-the-counter medicines are often the only written guidance a consumer reads before taking a product. This review summarises published work on what national and regional regulations require on such labels, how compliance has been audited, which deficiencies are reported most often, and what is known about consumer comprehension. It also covers dosing devices, pictograms and readability testing. The literature indicates that formal compliance and real understanding are separate things, that dosing and active-ingredient information cause most of the documented problems, and that audit methods are poorly standardised. No new audit data are reported, and the conclusions rest on regulatory documents and studies by others.