Phenylbutazone

Manufacturer
Covetrus North America | Vetoquinol USA, Inc. | Med-Pharmex, Inc. | Sintenovo SA DE CV
Effective date
2019-10-23
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:06:12

Label at a glance#

ProductPhenylbutazone
Active ingredientPhenylbutazone
Label structure13 sections

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 11695-4858-1

ANADA 200-266, Approved by the FDA.

For animal use only

DESCRIPTION SECTION

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 SECTION

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

CONTRAINDICATIONS SECTION

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

FOOD SAFETY WARNING SECTION

WARNING: Not for use in horses intended for food.

PRECAUTIONS SECTION

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 SECTION

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

SPL UNCLASSIFIED SECTION

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 SECTION

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

HOW SUPPLIED SECTION

HOW SUPPLIED: Syringes containing 20 g of Phenylbutazone.

SAFE HANDLING WARNING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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:

PRINCIPAL DISPLAY PANEL - 60 mL Syringe Label
PRINCIPAL DISPLAY PANEL - 60 mL Syringe Label

Products#

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DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11695-485811695-4858-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
PhenylbutazoneGN5P7K3T8SACTIB

Source Document#

Source XML · Source PDF

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.