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Animal NDC 11695-2210-1 Bismuth Subsalicylate

Animal Product Information

Field Name Field Value
Animal NDC Code 11695-2210-1
Proprietary Name Bismuth Subsalicylate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Bismuth Subsalicylate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Butler Animal Health Supply, Llc Dba Covetrus North America
Product Type Otc Animal Drug
Usage Information
    A palatable oral suspension for use as an aid in controlling simple diarrhea in cattle, horses, dogs, and cats.
Active Ingredient(s)
  • Bismuth Subsalicylate
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Bismuth Subsalicylate Images

Bismuth Subsalicylate Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Otc - Purpose



anti-diarrheal
Oral suspension


Otc - 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.


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 15° to 30°C (59°-86°F). Keep container tightly closed when not in use.


Otc - 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


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.