Dr. H. Shonna Yin of the New York University School of Medicine and Bellevue Hospital Center in New York and colleagues say the U.S. Food and Drug Administration in 2009 released voluntary guidelines to industry groups responsible for manufacturing, marketing, or distributing over-the-counter liquid medications, particularly for children because of unintentional overdoses that were attributed, in part, to products with inconsistent or confusing labels and measuring devices.
The researchers examined 200 top-selling pediatric oral liquid over-the-counter medications at the time the FDA guidelines were released. The analysis was conducted for one year, ending Oct. 30, 2009.
The study, published in the Dec. 15 issue of the Journal of the American Medical Association, found a standardized measuring device was provided for 148 products -- 74 percent -- but of the 148 products, 98.6 percent contained one or more inconsistencies between the labeled directions and the accompanying device. Almost one-quarter of products lacked necessary markings.
"Among the measuring devices, 81.1 percent included 1 or more superfluous markings. The text used for units of measurement was inconsistent between the product's label and the enclosed device in 89 percent of products," the study authors say in a statement. "A total of 11 products used non-standard units of measurement, such as drams, cubic centimeters, or fluid ounces, as part of the doses listed."
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