Label: PANACUR- fenbendazole suspension

  • NDC Code(s): 57926-087-01
  • Packager: Merck Sharp & Dohme Corp.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL

Drug Label Information

Updated September 10, 2021

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  • INDICATIONS AND DOSAGE:

    Horses – 2.3 mg/lb (5 mg/kg): for the treatment and control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris, Triodontophorus spp.), small strongyles (Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp.), and pinworms (Oxyuris equi). 4.6 mg/lb (10 mg/kg): for the treatment and control of ascarids (Parascaris equorum).

    Beef and Dairy Cattle – 2.3 mg/lb (5 mg/kg): for the treatment and control of: Lungworms: Adult Dictyocaulus viviparus; Stomach worms: Adult brown stomach worms (Ostertagia ostertagi), Adult and fourth stage larvae barberpole worms (Haemonchus contortus & H. placei) and Adult and fourth stage larvae small stomach worms (Trichostrongylus axei); Intestinal worms (Adult and fourth stage larvae): hookworms (Bunostomum phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata & C. oncophora), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum).

    Beef Cattle Only – 4.6 mg/lb (10 mg/kg): for the treatment and control of: Stomach worms (4th stage inhibited larvae): Ostertagia ostertagi (Type II Ostertagiasis); Tapeworms: Moniezia benedeni.

    Do not use in dairy cattle at 10 mg/kg.

  • STORAGE AND HANDLING

    Shake well before use.

    Store at or below 25°C (77°F)

    Protect from freezing.

  • DIRECTIONS:

    Horses and Beef and Dairy Cattle:

    Administer orally by suitable dosing syringe. Insert nozzle of syringe through the interdental space and deposit the drug on the back of the tongue by depressing the plunger. The drug may also be administered by stomach tube.

    EXAMPLES:

    Animal WeightDose
    (5 mg/kg)
    Dose
    (10 mg/kg)
    100 lb2.3 mL4.6 mL
    200 lb4.6 mL9.2 mL
    300 lb6.9 mL13.8 mL
    400 lb9.2 mL18.4 mL
    500 lb11.5 mL23.0 mL
    1000 lb23.0 mL46.0 mL
    1500 lb34.5 mL69.0 mL

    Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.

  • WARNINGS

    WARNINGS: NOT FOR USE IN HUMANS. KEEP OUT OF REACH OF CHILDREN. The Safety Data Sheet (SDS) contains more detailed occupational safety information. For customer service, adverse effects reporting, and/or a copy of the SDS, call 1-800-211-3573. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDAVETS, http://www.fda.gov/reportanimalae.

  • WARNINGS

    OTHER WARNINGS: Do not use in horses intended for human consumption.

    Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers. Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance. Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method). A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.

  • SPL UNCLASSIFIED SECTION

    Fenbendazole (active ingred.) made in China.
    Formulated in France.
    Distributed by:
    Intervet Inc. (d/b/a Merck Animal Health) Madison, NJ 07940
    Approved by FDA under NADA # 104-494
    Approved by FDA under NADA # 128-620
    ©2020 Intervet Inc., a subsidiary of Merck & Co. Inc.
    Rev. 11/20

    LOT
    NUMBER:

    EXPIRATION
    DATE:

    312522 R11

  • PRINCIPAL DISPLAY PANEL - 1,000 mL Bottle Label

    panacur®
    (fenbendazole)

    Horse & Cattle
    Dewormer

    Suspension 10%
    (100 mg/mL)

    Withdrawal Periods and Residue Warnings: Milk taken
    from cows during treatment and for 48 hours after the last
    treatment must not be used for human consumption. Cattle
    must not be slaughtered for human consumption within
    8 days following last treatment with this drug product.
    Not for use in beef calves less than 2 months of age, dairy
    calves, and veal calves. A withdrawal period has not been
    established for this product in pre-ruminating calves.

    CAUTION: Federal law restricts this drug to use
    by or on the order of a licensed veterinarian.

    1,000 mL (33.8 fl oz)

    MERCK
    Animal Health

    328771 R8

    PRINCIPAL DISPLAY PANEL - 1,000 mL Bottle Label

  • INGREDIENTS AND APPEARANCE
    PANACUR 
    fenbendazole suspension
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:57926-087
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Fenbendazole (UNII: 621BVT9M36) (Fenbendazole - UNII:621BVT9M36) Fenbendazole100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    trisodium citrate dihydrate (UNII: B22547B95K)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57926-087-011000 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA12862011/15/1977
    Labeler - Merck Sharp & Dohme Corp. (001317601)
    Establishment
    NameAddressID/FEIBusiness Operations
    Intervet Production S.A.771867553ANALYSIS, MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd420823163API MANUFACTURE