FDA Recommendations

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FDA Advisory Board Recommendations for Dosing Single Ingredient Children's Acetaminophen & Acetaminophen Quick Facts

Citizens Reply to FDA 2021 Response

“Petitioner urgently requests that the Agency take immediate action to comply with and implement the Agency’s own appointed advisory board’s dosing recommendations and to judiciously enforce Sec.502(a)[21 U.S.C.] of the U.S. FD&C Act.”

FDA Citizens Petition
2020

“Petitioner requests the FDA amend the Children’s OTC dosage schedule and directions of Children’s Single Ingredient Acetaminophen for the 2 to under 4 years of age group as published in the TFM of 1988.”

FDA Citizens Petition
2024

“Petitioner requests the FDA to issue a notice of compliance and publish a statement of enforcement requiring the removal and further use of specific labeling and directions from all over-the counter (OTC) single-ingredient acetaminophen products for 2-3 year of age, 24-35 lb Infants.”

FDA Citizens Petition FDA Response 2021

“The FDA has been unable to reach a decision on your petition because it raises complex issues requiring extensive review and analysis by Agency officials. We will respond to your petition as soon as we have reached a decision.”

FDA Citizens Petition FDA Response 2024

“The FDA intends to issue a proposed safety related order on pediatric acetaminophen dosing that addresses dosage strengths of oral, single-ingredient pediatric acetaminophen products, and will propose adding weight- and age-based dosing for children under the age of 12.”