Phenylbutazone by Covetrus North America / Vetoquinol USA, Inc. / Med-Pharmex, Inc. / Sintenovo SA DE CV PHENYLBUTAZONE paste

Phenylbutazone by

Drug Labeling and Warnings

Phenylbutazone by is a Animal medication manufactured, distributed, or labeled by Covetrus North America, Vetoquinol USA, Inc., Med-Pharmex, Inc., Sintenovo SA DE CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

NDC: 11695-4858-1

ANADA 200-266, Approved by the FDA.

For animal use only

DESCRIPTION

DESCRIPTION: Phenylbutazone Paste is a synthetic, non-hormonal anti-inflammatory, antipyretic compound useful in the management of inflammatory conditions. The apparent analgesic effect is probably related mainly to the compound's anti-inflammatory properties. Chemically, Phenylbutazone Paste is 4-butyl-1, 2-diphenyl-3, 5-pyrazolidinedione. It is a pyrazolone derivative, entirely unrelated to the steroid hormones.

VETERINARY INDICATIONS

INDICATIONS: For the relief of inflammatory conditions associated with the musculoskeletal systems in horses.

CONTRAINDICATIONS

CONTRAINDICATIONS: Use with caution in patients who have a history of drug allergy.

FOOD SAFETY WARNING

WARNING: Not for use in horses intended for food.

PRECAUTIONS

PRECAUTIONS: Stop medication at the first sign of gastrointestinal upset, jaundice, or blood dyscrasia. Authenticated cases of agranulocytosis associated with the drug have occurred in man; fatal reactions, although rare, have been reported in dogs after long-term therapy. To guard against this possibility, conduct routine blood counts at weekly intervals during the early phase of therapy and at intervals of two weeks thereafter. Any significant fall in the total white blood cell count, relative decrease in granulocytes, or black or tarry stools should be regarded as a signal for immediate cessation of therapy and institution of appropriate counter-measures. In the treatment of inflammatory conditions associated with infections, specific anti-infective therapy is required.

DOSAGE & ADMINISTRATION

ADMINISTRATION AND DOSAGE: Orally - 1 to 2 g of phenylbutazone per 500 lb. of body weight daily. Do not exceed 4 g daily.

Guidelines to Successful Therapy: Use a relatively high dose for the first 48 hours, then reduce gradually to a maintenance dose. Maintain the lowest dose capable of producing desired clinical response. Response to Phenylbutazone Paste therapy is prompt, usually occurring within 24 hours. If no significant clinical effect is evident after five days, re-evaluate diagnosis and therapeutic approach.

When administering Phenylbutazone Paste, the oral cavity should be empty. Deposit paste on back of tongue by depressing plunger that has been previously set to deliver the correct dose. Many chronic conditions will respond to Phenylbutazone Paste therapy, but discontinuance of treatment may result in recurrence of symptoms.

STORAGE AND HANDLING

STORAGE: Store at 15°-30°C (59°-86°F).

HOW SUPPLIED

HOW SUPPLIED: Syringes containing 20 g of Phenylbutazone.

SAFE HANDLING WARNING

KEEP OUT OF REACH OF CHILDREN

SPL UNCLASSIFIED SECTION

CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

SPL UNCLASSIFIED SECTION

Manufactured by:
Med-Pharmex, Inc.
Pomona, CA 91767-1861

PRINCIPAL DISPLAY PANEL - 60 mL Syringe Label

Covetrus

NDC #11695-4858-1

Phenylbutazone
Paste for horses

For animal use only

APPLE FLAVOR

Each syringe contains 20 g phenylbutazone.

Each 3 mL marking on the plunger contains Phenylbutazone: 1 g.

Indications: For the relief of inflammatory conditions associated
with the musculoskeletal system in horses.

Dosage: 1 to 2 g of phenylbutazone per 500 lb body weight, but not
to exceed 4 g daily. Oral cavity should be empty. Deposit paste on
the back of tongue by depressing plunger that has been previously
set to deliver the correct dose.

WARNING: Not for use in horses intended for food.

CAUTION: Federal (U.S.A.) law restricts this drug to use by or on
the order of a licensed veterinarian.

KEEP OUT OF REACH OF CHILDREN

See package insert for additional information.

Store at 15°-30°C (59°-86°F).

ANADA #200-266, Approved by FDA

Net Volume: 2.02 fl oz (60 mL)

Reorder #044015

Questions?

(855) 724-3461

Distributed by:
Covetrus North America
Dublin, OH 43017

covetrus.com

AH-044015-L-01

REV:08/19

Lot #/Exp. Date:

INGREDIENTS AND APPEARANCE

PHENYLBUTAZONE 
phenylbutazone paste

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 11695-4858
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Phenylbutazone (UNII: GN5P7K3T8S) (Phenylbutazone - UNII:GN5P7K3T8S)	Phenylbutazone	35.1 g  in 100 g

Product Characteristics
Color		Score
Shape		Size
Flavor	APPLE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-4858-1	60 g in 1 SYRINGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200266	10/24/2019

Labeler - Covetrus North America (603750329)

Registrant - Vetoquinol USA, Inc. (106824209)

Establishment
Name	Address	ID/FEI	Business Operations
Med-Pharmex, Inc.		025353699	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Sintenovo SA DE CV		812039808	API MANUFACTURE