DIFIXN- loperamide hydrochloride tablet 
Goldman Pharmaceutical Group Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Difixn™

Drug Facts

Active ingredientPurpose
Loperamide HCl 2 mgAnti-diarrheal

Uses For the temporary relief of diarrhea

Warnings

Directions

Other information

Inactive Ingredients

cellulose, corn starch, D&C Yellow #10, dicalcium phosphate, FD&C Blue #1, magnesium stearate, silica gel

PRINCIPAL DISPLAY PANEL - 2 mg Caplet Bottle Label

pet
otc™
over the counter

Difixn™
Loperamide HCl 2 mg

ANTI-DIARRHEAL

10 to
60 lbs

20 CAPLETS

MADE IN THE USA

#1 VETERINARIAN
RECOMMENDED

PRINCIPAL DISPLAY PANEL - 2 mg Caplet Bottle Label
DIFIXN 
loperamide hydrochloride tablet
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:72087-013(NDC:66424-735)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorGREEN (green) Score2 pieces
ShapeOVALSize10mm
FlavorImprint Code 44;375
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72087-013-2020 in 1 BOTTLE
2NDC:72087-013-4040 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER05/01/2019
Labeler - Goldman Pharmaceutical Group Inc (080389804)
Registrant - Goldman Pharmaceutical Group, Inc. (080389804)
Establishment
NameAddressID/FEIBusiness Operations
Goldman Pharmaceutical Group, Inc.080389804RELABEL

Revised: 4/2019
Document Id: edfa6c48-163e-423c-866e-e31dc5d96096
Set id: efd14a74-447c-45fc-989a-01154f719f5d
Version: 1
Effective Time: 20190422
 
Goldman Pharmaceutical Group Inc