Label: PHENYLBUTE - phenylbutazone paste 

  • Label RSS
  • NDC Code(s): 57319-602-73
  • Packager: Clipper Distributing Company LLC
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated 09/12

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  • DESCRIPTION

    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.

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  • INDICATIONS & USAGE

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

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  • CONTRAINDICATIONS



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

    WARNING: Not for use in horses intended for food.

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  • PRECAUTIONS



    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.
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  • DOSAGE & ADMINISTRATION

    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.

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  • STORAGE AND HANDLING

    STORAGE: Store at 15oC - 30oC (59o-86oF)

    KEEP OUT OF REACH OF CHILDREN

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  • HOW SUPPLIED

    HOW SUPPLIED: Syringes containing 20 g of Phenylbutazone

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  • PRINCIPAL DISPLAY PANEL

    Phenylbutazone Paste for Horses
    Syringe label
    Package Insert



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  • INGREDIENTS AND APPEARANCE
    PHENYLBUTE 
    phenylbutazone paste
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:57319-602
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Phenylbutazone (Phenylbutazone) Phenylbutazone 35.1 g  in 100 g
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor APPLE (Apple Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57319-602-73 60 g in 1 SYRINGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200266 08/31/2012
    Labeler - Clipper Distributing Company LLC (150711039)
    Registrant - Med-Pharmex, Inc (025353699)
    Establishment
    Name Address ID/FEI Business Operations
    Med-Pharmex, Inc 025353699 manufacture
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