GASTRO-COTE- bismuth subsalicylate suspension

Gastro-Cote by

Drug Labeling and Warnings

Gastro-Cote by is a Animal medication manufactured, distributed, or labeled by Henry Schein Animal Health, First Priority Incorporated, 5N Plus Lübeck GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Anti-Diarrheal Liquid
Palatable 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.

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:
Henry Schein Animal Health
Dublin, OH 43017
www.henryscheinvet.com

Manufactured by:
First Priority, Inc.
Elgin, IL 60123

AH-002518-01
Rev. 0917

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GASTRO-COTE 
bismuth subsalicylate suspension

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-2169
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	17.4 g  in 1 L

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-2169-1	4 in 1 CASE
1		3.785 L in 1 JUG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/01/2013

Labeler - Henry Schein Animal Health (603750329)

Establishment
Name	Address	ID/FEI	Business Operations
First Priority Incorporated		179925722	manufacture, label, api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
5N Plus Lübeck GmbH		316594993	api manufacture