Advil Multi-Symptom Cold and Flu
Drug Facts
Approved
Approval ID
7671d104-3c5c-4f63-b6b1-6c91c22592f8
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 9, 2025
Manufacturers
FDA
Haleon US Holdings LLC
DUNS: 079944263
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
chlorpheniramine maleate, ibuprofen, phenylephrine HCl
PRODUCT DETAILS
NDC Product Code0573-0190
Application NumberNDA022113
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateApril 9, 2025
Generic Namechlorpheniramine maleate, ibuprofen, phenylephrine HCl
INGREDIENTS (25)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
SOYBEAN LECITHINInactive
Code: 1DI56QDM62
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CHLORPHENIRAMINE MALEATEActive
Quantity: 4 mg in 1 1
Code: V1Q0O9OJ9Z
Classification: ACTIB
IBUPROFENActive
Quantity: 200 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 04JA59TNSJ
Classification: ACTIB
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT