Label: BUTAPASTE- phenylbutazone paste

  • NDC Code(s): 11695-4851-1
  • Packager: Butler Animal Health Supply LLC dba Henry Schein Animal Health
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated June 27, 2016

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    NDC 11695-4851-1

    ANADA 200-266, Approved by the FDA.

    For Veterinary Use Only

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

  • VETERINARY INDICATIONS

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

  • CONTRAINDICATIONS

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

  • FOOD SAFETY WARNING

    WARNING: Not for use in horses intended for food.

  • 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.

  • 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 the 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

    STORAGE: Store at 15°-30°C (59°-86°F).

  • HOW SUPPLIED

    HOW SUPPLIED: Syringes containing 20 g of Phenylbutazone.

  • SAFE HANDLING WARNING

    KEEP OUT OF REACH OF CHILDREN

  • SPL UNCLASSIFIED SECTION

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

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Med-Pharmex, Inc.
    Pomona, CA 91767-1861
    rev 06/12

  • PRINCIPAL DISPLAY PANEL - 60 mL Syringe Label

    HENRY SCHEIN®
    ANIMAL HEALTH

    NDC #11695-4851-1

    ANADA #200-266, Approved by FDA

    BUTAPASTE
    Phenylbutazone Paste for Horses

    FOR VETERINARY USE ONLY

    APPLE FLAVOR

    Each syringe contains 20 g phenylbutazone.

    Each 3 mL marking on the plunger contains Phenylbutazone: 1 g.

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

    Dosage: 1 to 2 g of phenylbutazone per 500 lb body weight, but not
    to exceed 4 g daily. Oral cavity should be empty. Deposit paste on
    the back of tongue by depressing plunger that has been previously
    set to deliver the correct dose.

    WARNING: Not for use in horses intended for food.

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

    KEEP OUT OF REACH OF CHILDREN

    See package insert for additional information.

    Store at 15°-30°C (59°-86°F).

    Net Volume: 60 mL

    Reorder #044015

    Distributed Exclusively by
    Henry Schein Animal Health
    Dublin, OH 43017

    www.henryscheinvet.com

    HENRY SCHEIN
    SEAL OF EXCELLENCE

    VetUS™

    Lot #/Exp. Date:

    Rev. 06/13

    PRINCIPAL DISPLAY PANEL - 60 mL Syringe Label
  • INGREDIENTS AND APPEARANCE
    BUTAPASTE 
    phenylbutazone paste
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:11695-4851
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Phenylbutazone (UNII: GN5P7K3T8S) (Phenylbutazone - UNII:GN5P7K3T8S) Phenylbutazone35.1 g  in 100 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorAPPLEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11695-4851-160 g in 1 SYRINGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20026608/14/2012
    Labeler - Butler Animal Health Supply LLC dba Henry Schein Animal Health (017880659)
    Registrant - Vetoquinol USA, Inc. (106824209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Med-Pharmex, Inc.025353699MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Sintenovo SA DE CV812039808API MANUFACTURE