ORAL-PRO BIZ-KOTE by Aurora Pharmaceutical, Inc. ORAL-PRO™BIZ-KOTE

ORAL-PRO BIZ-KOTE by

Drug Labeling and Warnings

ORAL-PRO BIZ-KOTE by is a Animal medication manufactured, distributed, or labeled by Aurora Pharmaceutical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ORAL-PRO BIZ-KOTE- bismuth subsalicylate suspension 
Aurora Pharmaceutical, Inc.

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.

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ORAL-PRO™
BIZ-KOTE

INDICATIONS:

A palatable oral suspension for use as an aid in controlling nonspecific diarrhea by coating intestinal mucosa, thereby decreasing hyperperistalsis and irritation.

CONTRAINDICATION:

Do not use products containing ORAL-PRO Biz-Kote in cats unless directed by your veterinarian. Dogs that may have an allergy to aspirin should not be given the formulation with ORAL-PRO Biz-Kote. Use with caution in dogs receiving aspirin.

CAUTION:

This product contains salicylate; do not administer with other salicylate-containing products, such as aspirin.

DOSAGE AND ADMINISTRATION:

Administer orally after the first sign of diarrhea and after each loose bowel movement or as needed.

Dogs — 1 to 3 tablespoonfuls
Calves — 3 to 4 fluid ounces
Foals — 3 to 4 fluid ounces
Cattle — 6 to 10 fluid ounces
Horses — 6 to 10 fluid ounces

Treatment should only be needed for 1–2 days. If the vomiting and/or diarrhea persists for more than 48 hours, contact your veterinarian.

This product may cause stools to darken.

COMPOSITION:

Bismuth Subsalicylate ……………… 1.75% w/v

In a palatable aqueous suspension.

Flavoring and coloring added.

SHAKE WELL BEFORE USING.

FOR ORAL USE ONLY.

KEEP FROM FREEZING.

Store at controlled temperature between 20°–25° C (68°–77° F). Excursions permitted between 15°–30° C (59°–86° F).

REORDER NO: 21007

MANUFACTURED BY:
Aurora Pharmaceutical, LLC
NORTHFIELD, MINNESOTA 55057
888-215-1256
www.aurorapharmaceutical.com
IN 50-1168 REV 01

MANUFACTURED IN THE USA

PRINCIPAL DISPLAY PANEL - 1 Gallon Bottle Label

NDC: 51072-050-01

ORAL-PRO™

BIZ-KOTE

Anti-Diarrheal Liquid

For Animal Use Only

Keep Out of Reach of Children

1 Gallon (3.79 L)

AURORA PHARMACEUTICAL®

ORAL-PRO BIZ-KOTE 
bismuth subsalicylate suspension

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 51072-050
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	1.75 g  in 100 mL

Product Characteristics
Color	pink	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51072-050-01	3790 mL in 1 BOTTLE
2	NDC: 51072-050-07	207 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/03/2014	02/29/2020

Labeler - Aurora Pharmaceutical, Inc. (832848639)

Establishment
Name	Address	ID/FEI	Business Operations
Aurora Pharmaceutical, Inc.		832848639	MANUFACTURE

Revised: 11/2019

Document Id: 03eb8c0c-92bc-4e96-a455-968644583c91

50577-6

Set id: 509f2b3f-e171-4117-b98d-154342749d65

Version: 4

Effective Time: 20191121

 

Aurora Pharmaceutical, Inc.