Evaluation of Consistency in Dosing Directions and Measuring Devices for Pediatric Nonprescription Liquid Medications

In November 2009, the US Food and Drug Administration (FDA) released voluntary guidelines recommending increased consistency and clarity in over-the-counter (OTC) medication dosing directions and measuring devices. A study to assess OTC pediatric liquid medication dosing directions and measuring devices at the time the guidelines were released found highly variable directions, devices and units of measurement within and across medications.

The authors examined 200 top-selling pediatric oral liquid OTC medicines, noting whether the medicine came with a measuring device, its dose amounts, dosing direction inconsistency between the medicine’s label and the measuring device, use of nonstandard abbreviations and units, and whether abbreviations were defined.

Of the 148 medications that came with a measuring device, 146 had dosing direction inconsistencies between the medicine’s label and the device, including both missing and extra markings on the device. Eleven medications used nonstandard units (drams, cc), and 97 used nonstandard abbreviations for units. Of the 163 medicines that lacked abbreviation definitions, 62.2 percent lacked information stating that the measuring device should only be used with its associated medicine.

The authors recommend including a standardized measuring device with OTC liquid medications, ensuring consistent dosing directions and measurements on the device and standardizing units and abbreviations across medications.