Pributazone

Generic Name: phenylbutazone tablets
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 Item Code (Source) NDC:58829-334
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLBUTAZONE (PHENYLBUTAZONE) PHENYLBUTAZONE 1 g
Product Characteristics
Color white (WHITE) Score 2 pieces
Shape ROUND (ROUND) Size 18mm
Flavor Imprint Code BUTE;1GM
Contains         
Packaging
# Item Code Package Description
1 NDC:58829-334-10 12 BOTTLE, PLASTIC (BOTTLE) in 1 CASE
1 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC
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: 06/2010
 
FIRST PRIORITY INCORPORATED



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