Label: THERABLOAT DRENCH- poloxalene concentrate

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/12

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

  • SPL UNCLASSIFIED SECTION

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

    For veterinary use only

    2 fl oz (59.1 mL)

    NADA #39-729, Approved by FDA

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

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  • 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 animals.

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  • 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.

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  • 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 gallon of water.

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  • Caution

    Keep out of reach of children.

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  • STORAGE AND HANDLING

    Store at Controlled Room Temperature 15°–30°C (59°–86°F)

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  • SPL UNCLASSIFIED SECTION

    For Animal Use Only

    Restricted Drug (California)—Use Only as Directed

    Not for Human Use

    Logo

    8620000
    Made in USA

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  • PRINCIPAL DISPLAY PANEL - 59.1 mL Bottle Label

    Therabloat®
    (poloxalene)

    Drench Concentrate

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

    For veterinary use only

    2 fl oz (59.1 mL)
    NADA #39-729, Approved by FDA

    Pfizer

    820685000
    LOT/EXP:

    PRINCIPAL DISPLAY PANEL - 59.1 mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    THERABLOAT   DRENCH
    poloxalene concentrate
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:61106-8620
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    poloxalene (poloxalene) poloxalene 25 g  in 30 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61106-8620-1 59.1 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA039729 05/12/1970
    Labeler - Pfizer Animal Health (039055157)
    Registrant - Pfizer Inc. (943955690)
    Establishment
    Name Address ID/FEI Business Operations
    Pharmacia and Upjohn Company 829076566 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    BASF Corporation 001307032 API MANUFACTURE
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