Label: VALBAZEN- albendazole suspension

  • NDC Code(s): 54771-8783-1, 54771-8783-2, 54771-8783-3
  • Packager: Zoetis Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated May 28, 2014

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  • DESCRIPTION

    Broad-Spectrum Dewormer

    Oral Suspension for Use in Cattle, Sheep, and Goats for removal and control of liver flukes, tapeworms, stomach worms (including 4th stage inhibited larvae of Ostertagia ostertagi), intestinal worms, and lungworms in cattle and sheep and for the treatment of adult liver flukes in nonlactating goats

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  • SPL UNCLASSIFIED SECTION

    Active Ingredient:
    Albendazole
    (Equivalent to 113.6 mg/mL)
    11.36%
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  • VETERINARY INDICATIONS

    Indications:

    Cattle and sheep: Valbazen is a broad-spectrum anthelmintic effective in the removal and control of liver flukes, tapeworms, stomach worms (including 4th stage inhibited larvae of Ostertagia ostertagi), intestinal worms, and lungworms as indicated below.

    Goats: For the treatment of adult liver flukes in nonlactating goats.

    Parasite Cattle Sheep Goats
    Adult Liver Flukes Fasciola hepatica Fasciola hepatica, Fascioloides magna Fasciola hepatica
    Heads and Segments of Tapeworms Moniezia benedeni, M. expansa Common Tapeworm (Moniezia expansa), Fringed Tapeworm (Thysanosoma actinioides)
    Adult and 4th Stage Larvae of Stomach Worms Brown Stomach Worm, including 4th stage inhibited larvae (Ostertagia ostertagi), Barber Pole Worm (Haemonchus contortus, H. placei), Small Stomach Worm (Trichostrongylus axei) Brown Stomach Worm (Ostertagia circumcincta, Marshallagia marshalli), Barber Pole Worm (Haemonchus contortus), Small Stomach Worm (Trichostrongylus axei)
    Adult and 4th Stage Larvae of Intestinal Worms Thread-necked Intestinal Worm (Nematodirus spathiger, N. helvetianus), Small Intestinal Worm (Cooperia punctata, C. oncophora) Thread-necked Intestinal Worm (Nematodirus spathiger, N. filicollis), Cooper's Worm (Cooperia oncophora), Bankrupt Worm (Trichostrongylus colubriformis), Nodular Worm (Oesophagostomum columbianum), Large-mouth Bowel Worm (Chabertia ovina)
    Adult Stages of Intestinal Worms Hookworm (Bunostomum phlebotomum), Bankrupt Worm (Trichostrongylus colubriformis), Nodular Worm (Oesophagostomum radiatum)
    Adult and 4th Stage Larvae of Lungworms Dictyocaulus viviparus
    Adult and Larval Stages of Lungworms Dictyocaulus filaria
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  • DOSAGE & ADMINISTRATION

    Dosage and Administration: Valbazen Suspension should be administered to cattle and goats at the recommended rate of 4 mL/100 lb of body weight (equivalent to 4.54 mg of albendazole/lb, 10 mg/kg) and to sheep at the recommended rate of 0.75 mL/25 lb of body weight (equivalent to 3.4 mg of albendazole/lb, 7.5 mg/kg). The following table indicates recommended dosing schedules.

    Cattle Sheep Goats
    Body Weight Dosage Body Weight Dosage Body Weight Dosage
    250 lb 10 mL 25 lb 0.75 mL 25 lb 1 mL
    500 lb 20 mL 50 lb 1.5 mL 50 lb 2 mL
    750 lb 30 mL 75 lb 2.25 mL 75 lb 3 mL
    1000 lb 40 mL 100 lb 3.0 mL 100 lb 4 mL
    1250 lb 50 mL 200 lb 6.0 mL 125 lb 5 mL
    1500 lb 60 mL 300 lb 9.0 mL 150 lb 6 mL

    Cattle: 1 liter of Valbazen 11.36% Suspension will treat 50 animals weighing 500 lb.

    Sheep: 1 liter of Valbazen 11.36% Suspension will treat 664 animals weighing 50 lb.

    Goats: 1 liter of Valbazen 11.36% Suspension will treat 500 animals weighing 50 lb.

    Valbazen 11.36% Suspension should be given orally using any type of standard dosing gun or dose syringe.

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  • SPL UNCLASSIFIED SECTION

    Important: Accurate estimates of the weight of the cattle, sheep, and goats to be treated are essential for most effective results with this product. Animals constantly exposed to internal parasites should be retreated as necessary.

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  • RESIDUE WARNING

    Residue Warnings: Cattle must not be slaughtered within 27 days following last treatment. Sheep and Goats must not be slaughtered within 7 days following last treatment. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. Do not use in lactating does.

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  • PRECAUTIONS

    Precaution: Do not administer to female cattle during first 45 days of pregnancy or for 45 days after removal of bulls. Do not administer to ewes or does during the first 30 days of pregnancy or for 30 days after removal of rams or bucks. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

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  • SPL UNCLASSIFIED SECTION

    Keep This and All Medication Out of Reach of Children

    Shake Well Before Using

    For Use in Animals Only

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  • STORAGE AND HANDLING

    Store at Controlled Room Temperature 20° – 25°C (68° – 77°F)

    Protect From Freezing

    Not for human use

    Restricted Drug (California) - Use only as directed

    Time Label

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    8784000
    13945200

    LOT
    EXP

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  • PRINCIPAL DISPLAY PANEL - 1 L/33.8 fl oz Bottle Label

    VALBAZEN®
    (albendazole)

    Broad-Spectrum Dewormer

    Oral Suspension for Use in Cattle, Sheep, and Goats
    for removal and control of liver flukes, tapeworms,
    stomach worms (including 4th stage inhibited
    larvae of Ostertagia ostertagi), intestinal worms,
    and lungworms in cattle and sheep and for the
    treatment of adult liver flukes in nonlactating goats

    Active Ingredient
    Albendazole
    (equivalent to 113.6 mg/mL)
    11.36%

    1 L/33.8 fl oz (1 qt 1.8 fl oz)

    NADA #110-048, Approved by FDA

    8784000
    13945100

    zoetis

    PRINCIPAL DISPLAY PANEL - 1 L/33.8 fl oz Bottle Label
    Close
  • PRINCIPAL DISPLAY PANEL - 5 L/169 fl oz Bottle Label

    VALBAZEN®
    (albendazole)

    Broad-Spectrum Dewormer

    Oral Suspension for Use in Cattle, Sheep, and Goats
    for removal and control of liver flukes, tapeworms,
    stomach worms (including 4th stage inhibited
    larvae of Ostertagia ostertagi), intestinal worms,
    and lungworms in cattle and sheep and for the
    treatment of adult liver flukes in nonlactating goats

    Active Ingredient
    Albendazole
    (equivalent to 113.6 mg/mL)
    11.36%

    5 L/169 fl oz (1 gal 1 qt 9 fl oz)

    NADA #110-048, Approved by FDA

    8785000
    13945600

    zoetis

    PRINCIPAL DISPLAY PANEL - 5 L/169 fl oz Bottle Label
    Close
  • PRINCIPAL DISPLAY PANEL - 500 mL/16.9 fl oz Bottle Label

    VALBAZEN®
    (albendazole)

    Broad-Spectrum Dewormer

    Oral Suspension for Use in Cattle, Sheep, and Goats
    for removal and control of liver flukes, tapeworms,
    stomach worms (including 4th stage inhibited larvae of
    Ostertagia ostertagi), intestinal worms, and lungworms
    in cattle and sheep and for the treatment of adult liver
    flukes in nonlactating goats

    Active Ingredient:
    Albendazole
    (Equivalent to 113.6 mg/mL)
    11.36%

    500 mL/16.9 fl oz (1 pt 1 fl oz)

    NADA #110-048, Approved by FDA

    zoetis

    PRINCIPAL DISPLAY PANEL - 500 mL/16.9 fl oz Bottle Label
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  • INGREDIENTS AND APPEARANCE
    VALBAZEN 
    albendazole suspension
    Product Information
    Product Type OTC ANIMAL DRUG Item Code (Source) NDC:54771-8783
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    albendazole (UNII: F4216019LN) (albendazole - UNII:F4216019LN) albendazole 113.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) 6 mg  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54771-8783-1 500 mL in 1 BOTTLE
    2 NDC:54771-8783-2 1000 mL in 1 BOTTLE
    3 NDC:54771-8783-3 5000 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA110048 06/13/1989
    Labeler - Zoetis Inc. (828851555)
    Establishment
    Name Address ID/FEI Business Operations
    Zoetis LLC 039055157 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    UQUIFA Mexico, S.A. DE C.V. 810105874 API MANUFACTURE
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