Label: DIFIXN- loperamide hydrochloride tablet

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated April 22, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • SPL UNCLASSIFIED SECTION

    Active ingredientPurpose
    Loperamide HCl 2 mgAnti-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

    PRINCIPAL DISPLAY PANEL - 2 mg Caplet Bottle Label
  • INGREDIENTS AND APPEARANCE
    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
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