All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2025-P-4513
Requests that the FDA amend and/or remove specific labeling and directions, explicitly; if possible, use weight to dose; from all Infant's OTC single-ingredient acetaminophen liquid drug formulations for 2-3 year of age, 24-35 lb.
Documents
9
Comments
0
Key Dates
Comment Period OpensSep 30, 2025
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
CDER
Citizen Petition
Parenteral Technologies LLC
amend and or remove specific
labeling and directions explicitly if possible
use weight to dose from all Infants
OTC single-ingredient acetaminophen liquid
drug formulations for 2-3 year of age 24-35 lb
Data from Regulations.gov