Label: PHENYLBUTAZONE powder

  • NDC Code(s): 13985-991-11, 13985-991-22
  • Packager: MWI/VetOne
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated September 21, 2020

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  • 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

    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

    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

    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

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

  • WARNING

    Do not use in horses intended for human consumption.

  • HUMAN WARNING

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

  • PRECAUTION

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

  • CLINICAL PHARMACOLOGY

    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

    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

    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 - Phenylbutazone Powder (1.1 lb jar)

    ​NDC 13985-013-11

    VETONE

    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.

    ANADA 200-334, Approved by FDA

    Net Contents: 1.1 lb (0.5 kg)

    1.1 Pound Jar Label

    1.1 Pound Onsert

  • Principal Display Panel - Phenylbutazone Powder (2.2 lb jar)

    NDC 13985-013-22

    VETONE™

    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.

    ANADA 200-334, Approved by FDA

    Net Contents: 2.2 lb (1 kg)

    2.2 pound Jar Label

    2.2. pound Onsert

  • INGREDIENTS AND APPEARANCE
    PHENYLBUTAZONE 
    phenylbutazone powder
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:13985-991
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLBUTAZONE (UNII: GN5P7K3T8S) (PHENYLBUTAZONE - UNII:GN5P7K3T8S) PHENYLBUTAZONE1 g  in 10 g
    Product Characteristics
    Colororange (Light orange powder) Score    
    ShapeSize
    FlavorORANGE (ORANGE FLAVOR) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13985-991-11500 g in 1 JAR
    2NDC:13985-991-221000 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20033405/01/2009
    Labeler - MWI/VetOne (019926120)