- FDA issues final guidance on liquid pediatric acetaminophen (drugstorenews.com)
Food and Drug Administration….published a final guidance regarding pediatric oral liquid OTC products containing acetaminophen to address…acetaminophen overdose associated with these products and to promote their safe use.
- single-ingredient acetaminophen oral liquids… use a concentration of 160 mg acetaminophen per 5 mL.
- the statements “160 mg/5 mL” or “160 mg per 5 mL” should be prominently presented… same font size as the active ingredient name
- Dosing directions should be provided only in mL.
- recommended use age range should reflect the same age range as stated in the Drug Facts Panel under the heading "Directions"
- any images of children on the carton should also be representative of the age group identified under "Directions."
