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Drug Product Composition: NCGC00024414-05

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$ API Ref.Price (USD/KG) : 20Xls

USFDA APPLICATION NUMBER - 21393 / DOSAGE - CAPSULE;ORAL - 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE(UNII: TC2D6JAD40)
(DIPHENHYDRAMINE - UNII:8GTS82S83M)
DIPHENHYDRAMINE HYDROCHLORIDE25mg
IBUPROFEN(UNII: WK2XYI10QM)
(IBUPROFEN - UNII:WK2XYI10QM)
IBUPROFEN200mg

Inactive Ingredients

Ingredient Name
LNK International, Inc.
Haleon US Holdings LLC
L.N.K. International, Inc.
Chain Drug Consortium, LLC
CVS Pharmacy
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
Freds Inc
Good Sense (Geiss, Destin & Dunn, Inc.)
P & L Development, LLC
TARGET Corporation
TOP CARE (Topco Associates LLC)
Walgreen Company
Walgreens
BUTYL ALCOHOL(8PJ61P6TS3)            
D&C RED NO. 33(9DBA0SBB0L)          
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C RED NO. 40(WZB9127XOA)    
GELATIN(2G86QN327L)  
GELATIN, UNSPECIFIED(2G86QN327L)           
LECITHIN, SOYBEAN(1DI56QDM62)           
MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U)         
POLYETHYLENE GLYCOL 600(NL4J9F21N9)          
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)   
POTASSIUM HYDROXIDE(WZH3C48M4T)
SHELLAC(46N107B71O)           
SORBITAN(6O92ICV9RU)  
SORBITOL(506T60A25R)  
TITANIUM DIOXIDE(15FIX9V2JP)           
WATER(059QF0KO0R)