Label: BISMUTH- bismuth subsalicylate suspension

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/13

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  • BISMUSOL

    Anti-Diarrheal Liquid

    Palatable Oral Suspension

    For Animal Use Only

    Keep Out of Reach of Children

    NET CONTENTS:

    1 Gallon

    (3.785 L)

    ASPEN

    Veterinary Resources, Ltd.

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  • INDICATIONS:

    A palatable oral suspension for use as an aid in controlling simple diarrhea in cattle, horses, dogs and cats.

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  • CAUTION:

    This product contains salicylate; do not administer with other salicylate-containing products, such as aspirin.  Do not administer to pregnant animals unless prescribed by a licensed veterinarian.

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  • DOSAGE AND ADMINISTRATION:

    Administer orally.

    Dogs and Cats: 1 - 3 tablespoonfuls every 1-3 hours

    Calves and Foals: 3 - 4 ounces every 2-3 hours

    Cattle and Horses: 6 - 10 ounces every 2-3 hours

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  • WARNING:

    If diarrhea persists after using this product for 2 days, contact a veterinarian.

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  • SPL UNCLASSIFIED SECTION

    Aspen LC:046066

    Manufactured for:

    Aspen Veterinary Resources, Ltd.

    Liberty, MO 64068, USA

    A125AP Rev. 07/12

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  • COMPOSITION:

    Bismuth Subsalicylate..........1.75%

    In a palatable aqueous suspension.

    Flavoring and coloring added.

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  • SHAKE WELL BEFORE USING. FOR ORAL USE ONLY. KEEP FROM FREEZING.  

    Store at controlled room temperature not above 37ºC (98.6ºF). 

    Restricted Drug.

    Use only as directed.

    Not for human use.

    TAKE TIME OBSERVE LABEL DIRECTIONS

    Lot No.           Exp. Date

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  • Package/Label Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    BISMUTH 
    bismuth subsalicylate suspension
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:46066-002
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BISMUTH SUBSALICYLATE (BISMUTH CATION) BISMUTH SUBSALICYLATE 18 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    GUAR GUM  
    POTASSIUM SORBATE  
    SACCHARIN SODIUM  
    METHYL SALICYLATE  
    WATER  
    D&C RED NO. 33  
    SILICON DIOXIDE  
    Product Characteristics
    Color pink Score     
    Shape Size
    Flavor WINTERGREEN Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46066-002-02 3785 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 06/09/2011
    Labeler - ASPEN VETERINARY (627265361)
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