DIFIXN- loperamide hydrochloride tablet

Difixn by

Drug Labeling and Warnings

Difixn by is a Animal medication manufactured, distributed, or labeled by Goldman Pharmaceutical Group Inc, Goldman Pharmaceutical Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient	Purpose
Loperamide HCl 2 mg	Anti-diarrheal

VETERINARY INDICATIONS

Uses For the temporary relief of diarrhea

WARNINGS

Warnings

• Not for use in the following breeds:
  collie, shelty, australian shepard, german shepard, old english sheep dog, long haired whippets
• Do not use with any other product containing Loperamide HCl
• ask a veterinarian before use if your dog has any chronic illness
• stop use and ask veterinarian if symptoms get worse or do not improve within 3 days
• ask a veterinarian or pharmacist if your dog is on any other medication
• keep out of reach of children in case of overdose contact poison control center
• not for human use

DOSAGE & ADMINISTRATION

Directions

• give one dose every 8 hours as needed, not to exceed 3 doses in 24 hours
• 10 - 25 lbs take 1/2 caplet, 26 - 40 lbs take 1 caplet, 41 - 60 lbs take 2 caplets
• If diarrhea persists for more then 48 hours contact your veterinarian

STORAGE AND HANDLING

Other information

• store at room temperature
  20° - 25° (66° - 78° F)

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

DIFIXN 
loperamide hydrochloride tablet

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 72087-013(NDC:66424-735)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)	LOPERAMIDE HYDROCHLORIDE	2 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	GREEN (green)	Score	2 pieces
Shape	OVAL	Size	10mm
Flavor		Imprint Code	44;375
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72087-013-20	20 in 1 BOTTLE
2	NDC: 72087-013-40	40 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		05/01/2019

Labeler - Goldman Pharmaceutical Group Inc (080389804)

Registrant - Goldman Pharmaceutical Group, Inc. (080389804)

Establishment
Name	Address	ID/FEI	Business Operations
Goldman Pharmaceutical Group, Inc.		080389804	RELABEL