FDA issues final guidance on liquid pediatric acetaminophen
WASHINGTON - The Food and Drug Administration on Wednesday published a final guidance regarding pediatric oral liquid OTC products containing acetaminophen to address ongoing concerns about the potential for acetaminophen overdose associated with these products and to promote their safe use.
Under the final guidance, all single-ingredient acetaminophen oral liquids for pediatric use should have a concentration of 160 mg acetaminophen per 5 mL. In addition, the statements “160 mg/5 mL” or “160 mg per 5 mL” should be prominently presented on the principal display panel of the container label and carton labeling immediately below or to the right of the active ingredient name (i.e., acetaminophen) and in the same font size as the active ingredient name. Dosing directions should be provided only in mL.
The guidance also directed marketers that any recommended use age range should reflect the same age range as stated in the Drug Facts Panel under the heading "Directions" and any images of children on the carton should also be representative of the age group identified under "Directions."
The product package should include an appropriate dosage delivery device using units of mL, such as a calibrated and labeled oral syringe or dosing cup, a picture of which should be on the packaging.
Many of these provisions have already been voluntarily adopted by consumer healthcare companies. Last fall the Consumer Healthcare Products Association announced several key changes in marketing pediatric acetaminophen products, namely:
Deleting “spoon” labeling (i.e., teaspoon, tablespoon) on dosing directions and dosing devices;
Specifying use of “mL” only in dosing directions and on devices; and
Deleting the provision in dosing directions of a definition of any volumetric unit of measure (i.e., mL = milliliter).
“The makers of OTC medicines fully support using mL as the standard unit of measurement on all liquid orally ingested OTC medicines for children, as we believe this uniformity will make proper dosing easier for parents,” stated Scott Melville, CHPA president and CEO, at the time of the fall announcement. “We know from recent a study released in Pediatrics that parents who used milliliter-only units made fewer dosing errors than those who used teaspoon or tablespoon units. We hope this change combined with the ongoing educational efforts of the CHPA Educational Foundation will contribute to a significant decline in medication errors.”