Direct Drug Reference & FDA Summary
Childrens Ibuprofen Oral Suspension (Ibuprofen) is an FDA-registered SUSPENSION formulation manufactured by PAI Holdings, LLC dba PAI Pharma, indicated for use in SUSPENSION.
Brand / GenericChildrens Ibuprofen Oral Suspension / Ibuprofen
NDC Number0121-1666
Dosage / RouteSUSPENSION (ORAL)
Label Listing ExpirationDate unavailable
Regulatory Registry Source: U.S. FDA National Drug Code DirectoryFDA Verified
Clinical Pharmacology
Indications & Usage
Childrens Ibuprofen Oral Suspension is listed as a SUSPENSION formulation in the SUSPENSION category. Consult official FDA labeling for full prescribing information.
Administration Context
Childrens Ibuprofen Oral Suspension is administered via the ORAL route as a SUSPENSION.
Administration Protocol
Prescribing Information
Refer to official FDA labeling or institutional protocols for complete dosage and administration instructions.
Safety Profile
Contraindications & Warnings
Consult the official FDA-approved labeling for complete contraindications, warnings, precautions, and patient-specific safety information.
National Drug Registry
Product and label metadata.
Marketing Category
ANDA
Route of Administration
ORAL
National Drug Code
0121-1666
Manufacturer / Labeler
PAI Holdings, LLC dba PAI Pharma
Dosage Form
SUSPENSION
Strength
See labeling
Application Number
ANDA214789
SPL Identifier
70b3589f-fd88-4a73-b758-0d456422bd27
WHO Regulatory Intelligence
Vaccine Safety Information
Access evidence-based safety data and clinical guidelines from global health resources.