MedPath
FDA Approval

Syncol Max

April 16, 2025

HUMAN OTC DRUG LABEL

Acetaminophen(500 mg in 1 1)
Caffeine(60 mg in 1 1)
Pyrilamine Maleate(15 mg in 1 1)

Manufacturing Establishments (1)

LNK International, Inc.

Laboratorios Sanfer, S.A. de C.V.

117025878

Products (1)

Syncol Max

83393-390

M013

OTC Monograph Drug (C200263)

ORAL

April 16, 2025

TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
Code: 362O9ITL9DClass: ACTIBQuantity: 500 mg in 1 1
CaffeineActive
Code: 3G6A5W338EClass: ACTIBQuantity: 60 mg in 1 1
Code: R35D29L3ZAClass: ACTIBQuantity: 15 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
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