Label: THERABLOAT DRENCH- poloxalene concentrate

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated April 7, 2020

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  • SPL UNCLASSIFIED SECTION

    Drench Concentrate

    For treatment of legume (alfalfa, clover) bloat in cattle

    For veterinary use only

    NADA #39-729, Approved by FDA

    Each fl oz (approx. 30 mL) contains 25 grams of poloxalene.

  • Indications

    Therabloat Drench Concentrate will relieve legume bloat in cattle within minutes when used as directed. For best results administer at the earliest sign of bloat. If bloat has progressed in its severity to the degree that the animal is down, other means of treatment also are recommended (rumenotomy-rumen puncture). For oral use only—not for injection. May be used in lactating dairy animals.

  • Dosage

    For animals up to 500 lb, use 1 fl oz of Drench Concentrate. For animals over 500 lb, use 2 fl oz of Drench Concentrate.

  • Directions for Preparing Drench

    Add the proper amount of concentrate to 1 pint of water. Mix well and administer using a drenching bottle. If a stomach tube is to be used, add concentrate to 1 gal of water.

  • Caution

    Keep out of reach of children.

  • Storage

    Store at 20° to 25°C (68° to 77°F), with excursions permitted between 15° and 37°C (59° and 99°F).

  • SPL UNCLASSIFIED SECTION

    For Animal Use Only

    Restricted Drug (California)—Use Only as Directed

    Not for Human Use

    8620000
    PAA036662

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    Made in USA

  • PRINCIPAL DISPLAY PANEL - Twelve 59.1 mL Bottle Carton

    Therabloat®
    (poloxalene)

    Drench Concentrate

    For treatment of legume (alfalfa, clover) bloat in cattle

    For veterinary use only

    Twelve 2 fl oz (59.1 mL) bottles

    NADA #39-729, Approved by FDA

    zoetis

    PRINCIPAL DISPLAY PANEL - Twelve 59.1 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    THERABLOAT  DRENCH
    poloxalene concentrate
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:54771-8620
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLOXALENE (UNII: V8B3K56SW0) (POLOXALENE - UNII:V8B3K56SW0) POLOXALENE25 g  in 30 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-8620-159.1 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA03972905/12/1970
    Labeler - Zoetis Inc. (828851555)