Pributazone

Dosage Form: FOR ANIMAL USE ONLY
INDICATIONS

Phenylbutazone is for relief of inflammatory conditions associated with the musculoskeletal system in horses.

PRECAUTION

Concomitant use with other antiinflammatory drugs, such as NSAIDS or corticosteroids, should be avoided or closely monitored. In the treatment of inflammatory conditions associated with infections, specific anti-infective therapy should be used concurrently.

Pributazone Dosage and Administration

Orally - 1 to 2 boluses per 500 lb. of body weight, but not to exceed 4 grams daily. Reduce dosage as symptoms regress.

PACKAGE INSERT INFORMATION

See package insert for complete instructions.

INGREDIENTS

Each bolus contains:

Phenylbutazone, U.S.P. .............................1 gram

Plus excipients.

Warning

Do not use in horses intended for human consumption.

STORAGE

Store at controlled room temperature between 15°-30°C (59°-86°F). Keep container tightly closed when not in use.

DISPLAY PANEL

NDC# 58829-334-10

Pributazone®

Boluses

(phenylbutazone)


For Oral Use in Horses Only

Non-steroidal anti-inflammatory drug (NSAID)


CAUTION: Federal (U.S.A.) law restricts this drug to use by

or on the order of a licensed veterinarian.

Federal (U.S.A.) law prohibits the extra-label use of this product

in female dairy cattle 20 months of age or older.


For Animal Use Only • Keep Out of Reach of Children


Net Contents: 100 Boluses


ANADA 200-433, Approved by FDA


Manufactured By:

FIRST PRIORITY, INC., Elgin, IL U.S.A.

Made in U.S.A.

www.prioritycare.com

IMAGE OF LABEL

image of label

Pributazone   phenylbutazone  tablet

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 58829-334 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLBUTAZONE (PHENYLBUTAZONE) PHENYLBUTAZONE 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color white (WHITE) Score 2 pieces Shape ROUND (ROUND) Size 18mm Flavor Imprint Code BUTE;1GM Contains

Packaging # NDC Package Description Multilevel Packaging 1 58829-334-10 12 BOTTLE In 1 CASE contains a BOTTLE, PLASTIC 1 100 TABLET In 1 BOTTLE, PLASTIC This package is contained within the CASE (58829-334-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200433	09/01/2009

Labeler - FIRST PRIORITY INCORPORATED (179925722)

Establishment
Name	Address	ID/FEI	Operations
FIRST PRIORITY INCORPORATED		179925722	manufacture

Establishment
Name	Address	ID/FEI	Operations
FIRST PRIORITY INCORPORATED		832925825	manufacture

Revised: 06/2010FIRST PRIORITY INCORPORATED