PHENYLBUTE

Manufacturer
Clipper Distributing Company LLC
Effective date
2023-10-11
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:42:22

Label at a glance#

ProductPHENYLBUTE
Active ingredientPHENYLBUTAZONE
Label structure13 sections

Dosage and administration

For Horses Only: Administer orally (using the 0.6  ounce (18 mL) scoop provided) on a small amount of palatable feed and mix well. Give 1 to 2 level scoops per 500 pounds of body weight, but do not exceed 4 scoops per animal daily. Use the high dose for the first 48 hours, then gradually reduce to a maintenance dose.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

For Oral Use In Horses Only

NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID)

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

DESCRIPTION

DESCRIPTION SECTION

Phenylbutazone chemically is 4-butyl-1,2-diphenyl-3,5-pyrazolidinedione. 

C19H20N2O2

Mol. Wt. 308.38

Each 10 grams of powder contains 1 gram phenylbutazone

INDICATIONS

INDICATIONS & USAGE SECTION

Phenylbutazone is for the relief of inflammatory conditions associated with the musculoskeletal system in horses. In the treatment of inflammatory conditions associated with infections, specific anti-infective therapy should be used concurrently.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

For Horses Only: Administer orally (using the 0.6  ounce (18 mL) scoop provided) on a small amount of palatable feed and mix well. Give 1 to 2 level scoops per 500 pounds of body weight, but do not exceed 4 scoops per animal daily. Use the high dose for the first 48 hours, then gradually reduce to a maintenance dose.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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

WARNING

RESIDUE WARNING SECTION

Do not use in horses intended for human consumption.

HUMAN WARNING

WARNINGS SECTION

Keep this and all medications out of the reach of children. Dispense in tight, child resistant containers.

PRECAUTION

PRECAUTIONS SECTION

Concomitant use with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided or closely monitored.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Phenylbutazone was first synthesized in 1948 and introduced into human medicine in 1949. Kuzell (1), (2), (3), Payne (4), Fleming (5) and Denko (6) demonstrated the clinical effectiveness of phenylbutazone in gout, gouty arthritis, acute arthritis, acute rheumatism and various other rheumatoid disorders in humans. Fabre (7), Domenjoz (8), Wilhelmi (9) and Yourish (10) 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 mice (11) and dogs (12).
Phenylbutazone has been used by Camberos (13) 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 period treatment of osteoarthritis of the stifle and hip, arthrosis of the trapezious muscles and general arthritis. Sutter (14) reported a favorable response in chronic equine arthritis of long duration, fair results in severely bruised mare and poor results in two cases where the condition was limited to the third phalanx.

HOW SUPPLIED

HOW SUPPLIED SECTION

Phenylbutazone Powder is supplied in 1.1 lb (0.5 kg) jars and 2.2 lb (1 kg) jars each containing a dispensing scoop. One level scoop delivers 10 grams of powder containing 1 gram of phenylbutazone.

References

REFERENCES SECTION

1. Kuzell, WC, Schaffarzick, RW, Naughler, WE, Gandia, C, and Mankle, EA: A.M.A. Arch. Inst. Med., 92:646 (1953).
2. Kuzell, WC, Schaffarzick, RW, Brown, B, and Mankle, EA: J.A.M.A., 149:729 (1952).
3. Kuzell, WC, and Schaffarzick, RW: Calif. Med., 77:319 (1952).
4. Payne, RW, Shelter, MR, Farr, CH, Hellbaum, AA, and Ishmall, WK: J. Lab. Clin. Med., 45:331 (1955).
5. Fleming, J, and Will, G: Ann. Rheumat., Dis., 12:95 (1953).
6. Denko, CW, and Rumi, D: American Pract., 6:1865 (1955).
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, and Burns, J: A.M.A. Arch. Ophth., 53:264 (1955).
11. Hazelton, LW, Tusing, TW, and Hollana, EG: J. Pharmacol. Exper. Ther., 109:387 (1953).
12. Ogilvie, FB, and Sutter, MD: Vet. Med. 52:492 (1957).
13. Camberos, HR: Rev. Med. Vet. (Buenos Aries), 38:9 (1956).
14. Sutter, MD: Vet. Med., 53:83 (1958).

Principal Display Panel - Phenylbute Powder (1.1 lb jar)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​NDC 57319-509-62

Phenylbute® Powder

(Phenylbutazone Powder)

For Oral Use In Horses Only

NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID)

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

Net Contents: 1.1 lb (0.5 kg)

Approved by FDA under ANADA # 200-334

0.5 Kg Jar Label0.5 Kg Jar Label

0.5 Kg Onsert Label0.5 Kg Onsert Label

Principal Display Panel - Phenylbute Powder (2.2 lb jar)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57319-509-61

Phenylbute® Powder

(Phenylbutazone Powder)

For Oral Use In Horses Only

NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID)

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

Net Contents: 2.2 lb (1 kg)

Approved by FDA under ANADA # 200-334

1 Kg Jar Label1 Kg Jar Label

1 Kg Onsert Label1 Kg Onsert Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1292465phenylbutazone 1 GM in 10 GM Oral PowderPSN2
1292465phenylbutazone 0.1 MG/MG Oral PowderSCD2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57319-509-61PHENYLBUTE1000 g in 1 JARPOWDER10002
57319-509-62PHENYLBUTE500 g in 1 JARPOWDER5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57319-509PHENYLBUTE (PHENYLBUTAZONE) POWDER [CLIPPER DISTRIBUTING COMPANY LLC]22 package rows20231013_1924222f-a5b7-4fc9-9d6d-e9277c1fb01b.zip

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
57319-50957319-509-62, 57319-509-61

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.