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Drug Product Composition: Paracetamol

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$ API Ref.Price (USD/KG) : 7Xls

USFDA APPLICATION NUMBER - 20232 / DOSAGE - CAPSULE;ORAL - 325MG;50MG;40MG;30MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D)
ACETAMINOPHEN325mg
BUTALBITAL(UNII: KHS0AZ4JVK)
(BUTALBITAL - UNII:KHS0AZ4JVK)
BUTALBITAL50mg
CAFFEINE(UNII: 3G6A5W338E)
(CAFFEINE - UNII:3G6A5W338E)
CAFFEINE40mg
CODEINE PHOSPHATE(UNII: GSL05Y1MN6)
(CODEINE ANHYDROUS - UNII:UX6OWY2V7J)
CODEINE PHOSPHATE30mg

Inactive Ingredients

Ingredient Name
West-Ward Pharmaceuticals Corp
Actavis Pharma, Inc.
Breckenridge Pharmaceutical, Inc.
Par Pharmaceutical, Inc.
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)   
D&C RED NO. 33(9DBA0SBB0L)   
D&C RED NO. 7(ECW0LZ41X8)   
FD&C BLUE NO. 1(H3R47K3TBD) 
FD&C BLUE NO. 2(L06K8R7DQK)   
FD&C Red No. 3(PN2ZH5LOQY)  
FD&C Red No. 40(WZB9127XOA)   
FD&C Yellow No. 5(I753WB2F1M)   
FERRIC OXIDE RED(1K09F3G675)   
FERRIC OXIDE YELLOW(EX438O2MRT)   
FERROSOFERRIC OXIDE(XM0M87F357)   
GELATIN(2G86QN327L) 
GELATIN, UNSPECIFIED(2G86QN327L)   
LACTOSE MONOHYDRATE(EWQ57Q8I5X)   
MAGNESIUM STEARATE(70097M6I30) 
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)   
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)