The Food and Drug Administration recently held a meeting with the Consumer Healthcare Products Association, McNeil Consumer Healthcare and the American Academy of Pediatrics in order to review testimony surrounding dosing instructions on over-the-counter children’s medicine.
Over the years, mounting confusion over the lack of clear dosing instructions and measurement consistencies on over-the-counter children’s medication, specifically as they related to children under the age of 2, have been cited as the potential cause of many unintentional/accidental drug overdoses of children by their parents and caretakers.
As a result of the meeting, the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee voted to recommend that dosing information for children 6 months to 2 years be added to all over-the-counter children’s medicines containing acetaminophen. This is a change that has been approved by both doctors and drug manufacturers.
These groups also discussed various ways to improve product labeling, clarify dosing instructions, standardize measurement units and promote the inclusion of dosing illustrations on packaging.