Label: PANACUR- fenbendazole suspension

  • NDC Code(s): 57926-086-01
  • Packager: Merck Sharp & Dohme Corp.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated September 10, 2021

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

  • VETERINARY INDICATIONS

    INDICATIONS: Beef and Dairy Cattle - 2.3 mg/lb (5 mg/kg) body weight 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) body weight 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.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Administer orally. In beef and dairy cattle, the recommended dose of 2.3 mg/lb (5 mg/ kg) is achieved when 2.3 mL of the drug are given for each 100 lb of body weight. In beef cattle only, the recommended dose of 4.6 mg/lb (10 mg/kg) for treatment and control of Type II Ostertagiasis (4th stage inhibited larvae) or tapeworms is achieved when 4.6 mL of the drug is given for each 100 lb of body weight.

    EXAMPLES:

    Cattle WeightDose
    (2.3 mg/lb)
    Dose
    4.6 mg/lb
    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, or http://www.fda.gov/reportanimalae.

  • WARNINGS

    OTHER WARNINGS: 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.

  • STORAGE AND HANDLING

    Store at or below 25°C (77°F). Protect from freezing. Shake well before use.

  • 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 # 128-620
    ©2020 Intervet Inc., a subsidiary of Merck & Co. Inc.
    Rev. 11/20

    340358 R5

  • PRINCIPAL DISPLAY PANEL - 3,785 mL Bottle Label

    panacur®
    (fenbendazole)

    Dewormer
    for Beef & Dairy Cattle

    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 Gallon (3,785 mL)

    LOT NUMBER:

    EXPIRATION DATE:

    MERCK
    Animal Health

    359646 R3

    PRINCIPAL DISPLAY PANEL - 3,785 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    PANACUR 
    fenbendazole suspension
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:57926-086
    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:57926-086-013785 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA12862009/16/2009
    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