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Drug Product Composition: Loperamide/simeticone

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$ API Ref.Price (USD/KG) : 303Xls

USFDA APPLICATION NUMBER - 19860 / DOSAGE - TABLET;ORAL - 2MG

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Loperamide Hydrochloride(UNII: 77TI35393C)
(Loperamide - UNII:6X9OC3H4II)
Loperamide Hydrochloride2mg

Inactive Ingredients

Ingredient Name
Lil' Drug Store Products, Inc.
REMEDYREPACK INC.
7-Eleven
American Sales Company
Amerisource Bergen
BJWC
Cardinal Health
Costco Wholesale Company
CVS Pharmacy
Dolgencorp, LLC
DZA Brands LLC
Family Dollar Services Inc
First Aid Direct
Harris Teeter, LLC
HyVee Inc
International Laboratories, LLC
Kinray
Kmart Corporation
Kroger Company
L. Perrigo Company
Lidl US LLC
Lil' Drug Store Products, Inc
Medex Merchandising, LLC
Shopko Stores Operating Co., LLC
Wakefern Food Corporation
Wal-Mart Stores Inc
WinCo Foods, LLC
Bedrock Brands, LLC
Chain Drug Consortium
Harmon Store Inc.
L.N.K. International, Inc.
NASH-FINCH COMPANY
Sam's West Inc
Honeywell Safety Products USA, Inc
Better Living Brands, LLC
CHAIN DRUG MARKETING ASSOCIATION INC
GREENBRIER INTERNATIONAL, INC.
H E B
Rite Aid Corporation
Walgreen Company
YYBA
Aurohealth LLC
FRED'S, INC.
L&R Distributors, Inc.
SDA Laboratories, Inc.
aluminum oxide(LMI26O6933)                                            
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)                                            
ANHYDROUS LACTOSE(3SY5LH9PMK)                   
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(O7TSZ97GEP)                                            
CARNAUBA WAX(R12CBM0EIZ)                      
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)                           
CORN OIL(8470G57WFM)                                           
CROSCARMELLOSE SODIUM(M28OL1HH48)                                         
Crospovidone (15 MPA.S AT 5%)(68401960MK)                                           
CROSPOVIDONE(68401960MK)                                           
D&C YELLOW NO. 10 ALUMINUM LAKE(CQ3XH3DET6)                                  
D&C YELLOW NO. 10(35SW5USQ3G)             
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)                            
FD&C BLUE NO. 1 ALUMINUM LAKE(J9EQA3S2JM)                                 
FD&C BLUE NO. 1(H3R47K3TBD)              
Hydrogenated Cottonseed Oil(Z82Y2C65EA)                                            
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)                                   
HYPROMELLOSES(3NXW29V3WO)                              
LACTOSE MONOHYDRATE(EWQ57Q8I5X)                                            
LACTOSE(J2B2A4N98G)                                            
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)                 
POLYETHYLENE GLYCOL(3WJQ0SDW1A)                                    
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)                                   
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)                                      
POWDERED CELLULOSE(SMD1X3XO9M)                                         
SILICON DIOXIDE(ETJ7Z6XBU4)                        
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)                                            
STARCH, CORN(O8232NY3SJ)                    
STARCH, PREGELATINIZED CORN(O8232NY3SJ)