Acetaminophen and Ibuprofen
Dual Action Pain Reliever ACETAMINOPHEN 250 mg & IBUPROFEN (NSAID) 125 mg TABLETS BACK PAIN
Approved
Approval ID
f0d3f0ab-07ee-f068-e053-2995a90a481a
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 2, 2025
Manufacturers
FDA
CVS
DUNS: 062312574
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen and Ibuprofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51316-132
Application NumberANDA216592
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetaminophen and Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateMay 2, 2025
FDA Product Classification
INGREDIENTS (21)
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
IBUPROFENActive
Quantity: 125 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
ACETAMINOPHENActive
Quantity: 250 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT