Phenylbute

Manufacturer
Clipper Distributing Company LLC | Med-Pharmex, Inc
Effective date
2012-09-29
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:44:51

Label at a glance#

ProductPhenylbute
Active ingredientPhenylbutazone
Label structure9 sections

Storage and handling

STORAGE : Store at 15 o C - 30 o C (59 o -86 o F) KEEP OUT OF REACH OF CHILDREN

Label contents#

Full prescribing information#

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 he compound's anti-inflammatory properties.
Chemically, Phenylbtazone Paste is 4-butyl-1,2-diphenyl-3-,5-pyrazolidinedione. It is a pyrazolone derivative, entirely unrelated to the steroid hormones.

INDICATIONS & USAGE SECTION

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

CONTRAINDICATIONS SECTION



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

WARNINGS 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.

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

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.

Guidelines to Successful Therapy: Use a relatively high dose for the first 48 hours, then reduce gradually to a maintenance dose. Maintain 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 15oC - 30oC (59o-86oF)

KEEP OUT OF REACH OF CHILDREN

HOW SUPPLIED SECTION

HOW SUPPLIED: Syringes containing 20 g of Phenylbutazone

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Phenylbutazone Paste for Horses
Syringe label
Syringe label
Package Insert
Package Insert

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PhenylbutazoneACTIVE INGREDIENTGN5P7K3T8S2
PhenylbutazoneACTIVE MOIETYGN5P7K3T8S2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57319-60257319-602-73

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.