Label: SYNANTHIC BOVINE DEWORMER- oxfendazole suspension 

  • Label RSS
  • NDC Code(s): 0010-3832-01, 0010-3832-02
  • Packager: Boehringer Ingelheim Vetmedica, Inc.
  • 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 11/13

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

  • SPL UNCLASSIFIED SECTION

    NADA 140-854, Approved by FDA

    For Animal Use Only

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  • DESCRIPTION

    Each mL contains 225 mg of oxfendazole. The entire contents of the 500 mL tube treats 110 cattle weighing approximately 500 lbs each, while the entire contents of the 1000 mL tube treats 220 cattle weighing approximately 500 lbs each.

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  • Indications:

    Synanthic Bovine Dewormer Suspension, 22.5%, is a broad-spectrum anthelmintic effective for the removal and control of the following parasites in cattle: lungworms, roundworms (including inhibited forms of Ostertagia ostertagi) and tapeworms, as indicated below:

    Lungworms:

    Dictyocaulus viviparus (Adult, L4)

    Stomach Worms:

    Barberpole Worms

    Haemonchus contortus (Adult)

    Haemonchus placei (Adult)

    Small Stomach Worms

    Trichostrongylus axei (Adult)

    Brown Stomach Worms

    Ostertagia ostertagi (Adult, L4, inhibited L4)

    Intestinal Worms:

    Nodular Worms

    Oesophagostomum radiatum (Adult)

    Hookworms

    Bunostomum phlebotomum (Adult)

    Small Intestinal Worms

    Cooperia punctata (Adult, L4)

    Cooperia oncophora (Adult, L4)

    Cooperia surnabada (Adult, L4)

    Tapeworms

    Moniezia benedeni (Adult)

    Consult a veterinarian for assistance in the diagnosis, treatment and control of parasitism.

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  • Administration and Dosage:

    Synanthic Bovine Dewormer Suspension, 22.5%, is supplied in 500 mL and one liter packages containing 225 mg of oxfendazole per mL. The recommended dose for cattle is 2.05 mg/lb (4.5 mg/kg) of body weight. Synanthic Bovine Dewormer Suspension, 22.5%, should be administered orally by accurate dose syringe at the rate of 1 mL per 110 lb (50 kg) of body weight. This product should be shaken well immediately prior to use.

    Remove Cap and Protective Seal and Replace with Blue Cap Prior to Use. Do Not Squeeze Sides of Bottle.

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  • Directions:

    Determine the proper dose according to estimated body weight. Administer orally. The recommended dose of 2.05 mg/lb (4.5 mg/kg) is achieved when 1 mL of the suspension is given for each 110 lb (50 kg) of body weight.

    Examples:

    Cattle Weight

    Dose

    110 lb (50 kg)

    1.0 mL

    220 lb (100 kg)

    2.0 mL

    330 lb (150 kg)

    3.0 mL

    440 lb (200 kg)

    4.0 mL

    550 lb (250 kg)

    5.0 mL

    660 lb (300 kg)

    6.0 mL

    770 lb (350 kg)

    7.0 mL

    880 lb (400 kg)

    8.0 mL

    990 lb (450 kg)

    9.0 mL

    1100 lb (500 kg)

    10.0 mL

    Treatment may be repeated in 4–6 weeks.

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  • Caution:

    Use only as directed. Keep out of reach of children. Not for human use.

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  • Residue Warnings:

    Cattle must not be slaughtered until 7 days after treatment. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age.

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  • Safety:

    There are no contraindications for the use of Synanthic Bovine Dewormer Suspension, 22.5%, in cattle.

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  • Storage:

    Store at or below 25°C (77°F). Brief excursions are permitted up to 30°C (86°F). Do not freeze.

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  • SPL UNCLASSIFIED SECTION

    Restricted Drug (California) – Use Only as Directed

    © 2012 Boehringer Ingelheim Vetmedica, Inc. All Rights Reserved.

    Synanthic is a registered trademark of Boehringer Ingelheim Vetmedica, Inc.

    80732325
    80729146, R.0
    383201-00
    B0G3

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  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Boehringer Ingelheim Vetmedica, Inc.
    St. Joseph, MO 64506 U.S.A.

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  • 500 mL tube container label
  • 500 mL Display Carton
  • INGREDIENTS AND APPEARANCE
    SYNANTHIC BOVINE DEWORMER 
    oxfendazole suspension
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:0010-3832
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OXFENDAZOLE (OXFENDAZOLE) OXFENDAZOLE 225 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0010-3832-01 1 in 1 CARTON
    1 500 mL in 1 TUBE
    2 NDC:0010-3832-02 1 in 1 CARTON
    2 1000 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA140854 12/21/2010
    Labeler - Boehringer Ingelheim Vetmedica, Inc. (007134091)
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