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Drug Product Composition: Dexibuprofen

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$ API Ref.Price (USD/KG) : 12Xls

USFDA APPLICATION NUMBER - 21394 / DOSAGE - TABLET;ORAL - 38MG;200MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE CITRATE(UNII: 4OD433S209)
(DIPHENHYDRAMINE - UNII:8GTS82S83M)
DIPHENHYDRAMINE CITRATE38mg
IBUPROFEN(UNII: WK2XYI10QM)
(IBUPROFEN - UNII:WK2XYI10QM)
IBUPROFEN200mg

Inactive Ingredients

Ingredient Name
Haleon US Holdings LLC
WYETH CONSUMER HEALTHCARE LLC
7-Eleven
Amerisource Bergen
Cardinal Health
CVS Pharmacy
DZA Brands LLC
HyVee Inc
Supervalu Inc
Wakefern Food Corporation
Walgreen Company
Dolgencorp Inc
H E B
Kmart Corporation
Shopko Stores Operating Co., LLC
CALCIUM STEARATE(776XM7047L)             
CARNAUBA WAX(R12CBM0EIZ)             
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)      
CROSCARMELLOSE SODIUM(M28OL1HH48)
FD&C BLUE NO. 2(L06K8R7DQK)       
FERROSOFERRIC OXIDE(XM0M87F357)     
GLYCERYL DIBEHENATE(R8WTH25YS2)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)         
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)          
HYDROXYPROPYL CELLULOSE(RFW2ET671P)             
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)              
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)             
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)  
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)       
POLYDEXTROSE(VH2XOU12IE)             
POLYETHYLENE GLYCOL(3WJQ0SDW1A)          
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)        
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)         
POLYVINYL ALCOHOL(532B59J990)     
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)          
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)             
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)             
STARCH, CORN(O8232NY3SJ)             
STEARIC ACID(4ELV7Z65AP)             
TALC(7SEV7J4R1U)  
TITANIUM DIOXIDE(15FIX9V2JP)