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# FDA Plans Pediatric Acetaminophen Safety Order
- URL: https://www.fdaweb.com/fda-plans-pediatric-acetaminophen-safety-order/
- Published: 2024-10-10T12:00:00.000Z
- Updated: 2026-09-14T14:43:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157959

In a 10/8 letter denying a Parenteral Technologies petition regarding enforcement of directions for pediatric acetaminophen, FDA indicates it intends to issue a proposed safety order on pediatric acetaminophen that addresses dosage strengths of oral, single-ingredient pediatric acetaminophen products, and will propose adding weight- and age-based dosing for children under age 12\. The original 4/14 petition asked that the agency:

- publish a statement of enforcement expressly prohibiting the further use of misleading, confusing, and inadequate directions for over-the-counter single-ingredient acetaminophen products for children aged 2-3 and weighing 24-35 pounds; and
- more specifically, issue a notice of compliance and publish a statement of enforcement requiring the removal and further use of labeling stating “if possible, use weight to dose.”

Parenteral Technologies said the current directions for use of the products are misleading, confusing, and inadequate; contrary to requirements in the Federal Food, Drug, and Cosmetic Act; and contrary to the format and content requirements for over-the-counter drug product labeling.

The agency response says that decisions on initiating enforcement actions are generally made by FDA on a case-by-case basis and are not an appropriate subject for a citizen petition, leading to denial of the petition.

The letter says FDA has included the proposed safety order in its Annual Forecast for Planned Monograph Activities, which covers a three-year horizon.