Syncol Max
Syncol 44-390
Approved
Approval ID
c844d5c4-3e4b-4169-904e-eb5c3334bc4e
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 16, 2025
Manufacturers
FDA
Laboratorios Sanfer, S.A. de C.V.
DUNS: 810007732
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen, Caffeine, Pyrilamine maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code83393-390
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Caffeine, Pyrilamine maleate
Product Specifications
Route of AdministrationORAL
Effective DateApril 16, 2025
FDA Product Classification
INGREDIENTS (16)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
ACETAMINOPHENActive
Quantity: 500 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CAFFEINEActive
Quantity: 60 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
PYRILAMINE MALEATEActive
Quantity: 15 mg in 1 1
Code: R35D29L3ZA
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT