VetriBute

Manufacturer
MWI | FIRST PRIORITY INCORPORATED
Effective date
2025-07-08
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:44:44

Label at a glance#

ProductVetriBute
Active ingredientPHENYLBUTAZONE
Label structure16 sections

Storage and handling

Store at controlled room temperature between 15°-30°C (59°-86°F). Keep container tightly closed when not in use. Lot No. Exp. Date

Label contents#

Full prescribing information#

DESCRIPTION SECTION

For Oral Use in Horses Only.

Non-steroidal anti-inflammatory drug (NSAID)

CAUTION:

PRECAUTIONS SECTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Federal law prohibits the extra-label use of this product in female dairy cattle 20 months of age or older.
Not for Use in Humans
Keep Out of Reach of Children
Approved by FDA under ANADA # 200-433

DESCRIPTION & PHARMACOLOGY:

DESCRIPTION SECTION

Phenylbutazone chemically is 4-butyl-1, 2- diphenyl-3, 5-pyrazolidinedione. It has the following structural formula:

image of phenylbutazone structureimage of phenylbutazone structure

Phenylbutazone was first synthesized in 1948 and introduced into human medicine in 1949, Kuzell1,2,3, Payne4, Fleming5, and Denko6, demonstrated the clinical effectiveness of phenylbutazone in gout, gouty arthritis, acute arthritis, acute rheumatism and various other rheumatoid disorders in humans. Fabre7, Domenjoz8, Wilhelmi9, and Yourish10, have established the anti-rheumatic and anti-inflammatory activity of phenylbutazone. It is entirely unrelated to the steroid hormones.
Toxicity of phenylbutazone has been investigated in rats and mice11, Ogilvie and Sutter12, have also made a study on the chronic toxicity of phenylbutazone in dogs. They have shown that dogs receiving 10 mg. and 100 mg. per Kg. body weight, per day for 90 days, maintain good appetites, excrete normal feces, gain weight and maintain a normal blood picture. They also report no abnormal macroscopic or microscopic changes in sacrificed animals which could have been attributed to the drug.
Phenylbutazone has been used by Camberos13 in thoroughbred horses. Favorable results were reported in cases of traumatism, muscle rupture, strains and inflammations of the third phalanx. Results were not as favorable in the periodic treatment of osteo-arthritis of medial and distal bones of the hock, arthritis of the stifle and hip, arthrosis of the trapezious muscles, and generalized arthritis. Sutter14 reported a favorable response in chronic equine arthritis of long duration, fair results in a severely bruised mare, and poor results in two cases where the condition was limited to the third phalanx.

INDICATIONS:

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

For horses only.
HORSES: Orally - 1 to 2 boluses per 500 lb. body weight. Do not exceed 4 grams daily. Reduce dosage as symptoms regress. Intermittent
treatment given only when symptoms appear may be indicated.

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INGREDIENTS:

SPL UNCLASSIFIED SECTION

Each bolus contains:
Phenylbutazone, U.S.P. ............................. 1 gram
Plus excipients.

CONTRAINDICATIONS:

CONTRAINDICATIONS SECTION

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

PRECAUTION:

PRECAUTIONS SECTION

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.

WARNING:

WARNINGS SECTION

Not for use in humans. Keep out of reach of children.

Keep Phenylbutazone Boluses in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

Do not use in horses intended for human consumption.

CONTACT INFORMATION:

ADVERSE REACTIONS SECTION

To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact First Priority, Inc. at (800) 650-4899 or www.prioritycare.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae

CAUTION:

PRECAUTIONS SECTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra-label use of this
product in female dairy cattle 20 months of age or older.

AVAILABILITY:

HOW SUPPLIED SECTION

Available in 1 gm. boluses - 100 boluses per bottle.

STORAGE:

STORAGE AND HANDLING SECTION

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

Lot No. Exp. Date

REFERENCES

REFERENCES SECTION

1. Kuzell, W.C., Schafferzick, R.W., Naughler, W.E., Gandia, G. and Mankle, E.A.: A.M.A. Arch. Inst. Med., 92; 646 (1953).
2. Kuzell, W.C., Schafferzick, R.W., Brown, B. and Mankle, E.A.: J.A.M.A. 149; 729 (1952).
3. Kuzell, W.C., and Schafferzick, R.W.: Calif. Med. 77; 319 (1952).
4. Payne, R.W., Shelter, M.R., Farr, C.H., Hellbaum, A.A. and Ishmall, W.K.: J. Lab. Clin. Med., 45; 331 (1955).
5. Fleming, J., and Will, G.: Ann. Rheumat. Dist., 12; 95 (1953).
6. Denko, C.W., and Rumi, D.: American Pract. 6; 1865 (1956).
7. Fabre, J., et al: Semain. Hop. (Paris) 31; 87 (1955).
8. Domenjoz, R., et al: Arzneimittel-Forsch, 5; 488 (1955).
9. Wilhelmi, G. and Pulver, R.: Arzneimittel- Forsch, 5; 221 (1955).
10. Yourish, W., Paton, B., Brodie, B., Burns, J.: A.M.A. Arch. Ophth., 53; 264 (1955).
11. Hazelton, L.W., Tusing, T.W. and Hollana, E.G.: J. Pharmacol. Exper. Ther., 109; 387 (1953).
12. Ogilvie, F.B. and Sutter, M.D.: Vet. Med. 52; 492-4 (1957).
13. Camberos, H.R.: Rev. Med. Vet. (Buenos Aires) 38; 9 (1956).
14. Sutter, M.D.: Vet. Med., 53; 83 (Feb. 1958).

INFORMATION FOR OWNERS/CAREGIVERS SECTION

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Distributed by: MWI
Boise, ID 83705
www.VetOne.net
Rev. 01/23

Net Contents: 100 Boluses

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of case labelimage of case labelimage of bottle labelimage of bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
243762phenylbutazone 1 GM Oral TabletPSN4
1487279VetriBute Bolus 1 GM Oral TabletPSN4
1487279phenylbutazone 1000 MG Oral Tablet [Vetribute]SBD4
243762phenylbutazone 1000 MG Oral TabletSCD4
243762phenylbutazone 1000 MG Oral BolusSY4
1487279Vetribute 1 GM Oral TabletSY4
1487279Vetribute 1000 MG Oral TabletSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13985-565-01VetriBute100 in 1 BOTTLE, PLASTICTABLET1004
13985-565-01VetriBute12 in 1 CASETABLET124

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PHENYLBUTAZONEACTIVE INGREDIENTGN5P7K3T8S1
PHENYLBUTAZONEACTIVE MOIETYGN5P7K3T8S1

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
13985-56513985-565-01

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

Reported adverse events (FAERS/openFDA)#

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