EXTRA STRENGTH PAIN RELIEF
GC ES apap liquid
Approved
Approval ID
e18294f5-8fd5-4ac6-802c-f6d257e8bee7
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
Preferred Pharmaceuticals Inc.
DUNS: 791119022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen
PRODUCT DETAILS
NDC Product Code68788-8375
Application Number343
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateMay 7, 2025
Generic NameAcetaminophen
INGREDIENTS (10)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
ACETAMINOPHENActive
Quantity: 500 mg in 15 mL
Code: 362O9ITL9D
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT