Difixn

Label at a glance#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient	Purpose
Loperamide HCl 2 mg	Anti-diarrheal

VETERINARY INDICATIONS SECTION

Uses For the temporary relief of diarrhea

WARNINGS SECTION

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 SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

• Difixn
• loperamide hydrochloride
• LOPERAMIDE
• STARCH, CORN
• DIBASIC CALCIUM PHOSPHATE DIHYDRATE
• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE
• SILICON DIOXIDE

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 7 · 123 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.