Label: BISMUTH SUBSALICYLATE suspension

  • NDC Code(s): 11695-2210-1
  • Packager: Butler Animal health Supply, LLC dba Covetrus North America
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated November 10, 2022

If you are a consumer or patient please visit this version.

  • PURPOSE

    anti-diarrheal
    Oral suspension

  • KEEP OUT OF REACH OF CHILDREN

    For animal use only
    Keep out of reach of children

  • HOW SUPPLIED

    1 Gallon (3.785 L)

  • Indications:

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

  • 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.

  • Dosage And Administration:

    Administer orally.
    Dogs and cats - 1 to 3 tablespoonfuls every 1-3 hours.
    Calves and foals - 3 to 4 ounces every 2-3 hours.
    Horses and cattle - 6 to 10 ounces every 2-3 hours.

  • WARNING:

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

    image description

  • Active Ingredient:

    Bismuth Subsalicylate ........................ 1.75% w/w

    In a palatable aqueous suspension. Flavoring and coloring added.

    Inactive Ingredients:

    Water, xanthan gum, magnesium salicylate, methyl salicylate, sodium saccharin, hydrochloric acid, methylparaben, propylparaben, and FD&C red #40.

  • Storage:

    Store at controlled room temperature between 15º to 30ºC (59º-86ºF). Keep container tightly closed when not in use.

  • WHEN USING

    SHAKE WELL BEFORE USING
    FOR ORAL USE ONLY
    KEEP FROM FREEZING

  • INFORMATION FOR OWNERS/CAREGIVERS

    Reorder #002518
    Questions? (855) 724-3461

    Distributed by:
    Covetrus North America
    400 Metro Place North
    Dublin, OH 43017
    covetrus.com


    AH-002518-02
    REV: 1019

  • PRINCIPAL DISPLAY PANEL

    image of bottle/case label

  • INGREDIENTS AND APPEARANCE
    BISMUTH SUBSALICYLATE 
    bismuth subsalicylate suspension
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-2210
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE17.4 g  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11695-2210-14 in 1 CASE
    13.785 L in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/13/2020
    Labeler - Butler Animal health Supply, LLC dba Covetrus North America (603750329)
    Establishment
    NameAddressID/FEIBusiness Operations
    First Priority Incorporated179925722manufacture, label, api manufacture