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# Change OTC Acetaminophen Children’s Dosage Schedule: Petition
- URL: https://www.fdaweb.com/change-otc-acetaminophen-childrens-dosage-schedule-petition/
- Published: 2020-12-17T12:00:00.000Z
- Updated: 2026-09-14T16:40:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148329

Parenteral Technologies is petitioning FDA to amend the children’s over-the-counter dosage schedule and directions of single-ingredient acetaminophen for ages 2-4 as published in the 11/16/88 tentative final monograph. The 11/21 [petition](https://downloads.regulations.gov/FDA-2020-P-2296-0001/attachment%5F1.pdf?ref=fdaweb.com) also asks the agency to publish a statement of enforcement policy expressly permitting manufacturers of children’s OTC single-ingredient acetaminophen to include labeling on the product that provides for the amended and expanded directions of use.

The petitioner says the requested changes “enable dosing methods that provide a narrowed consistent dose of children’s single-ingredient acetaminophen, in contrast to the variable dosing schedule commercially utilized and published within the tentative final monograph. In addition, these proposed amendments also provide for juxtaposed ancillary dosing indicia that correlate the predetermined dose to one or more known patient characteristics, thus providing for visual dose reverification.”