Label: SAFE-GUARD- fenbendazole granule

  • NDC Code(s): 57926-483-01, 57926-483-02, 57926-483-04
  • Packager: Merck Sharp & Dohme Corp.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated January 31, 2022

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

  • DOSAGE & ADMINISTRATION

    Directions: The daily dose for Safe-Guard® Canine is 50 mg/kg (22.7 mg/lb) of body weight. You should weigh your dog to make sure you are using the right dose; i.e. correct gram amount and appropriate number of pouches.

    Your dog must be treated with the following dose for 3 days in a row.

    Dog Weight
    (lbs)
    Pouch Size
    (Daily Dose)
    *
    Combine pouches to obtain recommended daily dosage.
    101 gram
    11 to 20 2 gram
    21 to 30*1 gram + 2 gram
    31 to 40 4 gram
    41 to 50*1 gram + 4 gram
    51 to 60*2 gram + 4 gram
    61 to 80*Two 4 gram
    Over 80*
    Mix daily dose with a small amount of the usual food. Make sure your dog eats all the medicated food. You may need to moisten dry dog food to aid mixing.
    Repeat the dose for 3 days in a row.

    Figure

  • SPL UNCLASSIFIED SECTION

    Recommended Deworming Schedule:

    Schedule may vary depending on the climate where you live and the activity of your dog. The following schedule should be used as a general guideline.

    • Weaned pups (6-8 weeks of age) should be dewormed at 6, 8, 10 and 12 weeks of age.
    • Treat the dam at the same time as the puppies.
    • Dogs over 6 months of age should be dewormed at least twice each year.
  • SPL UNCLASSIFIED SECTION

    Diagnosis of Parasites: Consult your veterinarian for help in the diagnosis, treatment and control of parasitism. Specific diagnoses require laboratory testing. Dogs can become infected with several different kinds of tapeworms. Safe-Guard® Canine only kills Taenia species of tapeworms. If you continue to see tapeworm segments in your dog's stool after treatment with Safe-Guard® Canine, consult your veterinarian.

    Roundworms and hookworms may pose serious human health risks; regular deworming may help reduce those risks.

  • INDICATIONS & USAGE

    Product Use: Safe-Guard® Canine is safe for use in puppies 6 weeks or older and adult dogs, including pregnant bitches. Do not deworm a dog or puppy that is sick. Consult your veterinarian for diagnosis of the illness.

  • ADVERSE REACTIONS

    Adverse Reactions: In U.S. clinical studies 3 of 240 dogs (about 1% of the treated dogs) had vomiting associated with the use of the product.

  • STORAGE AND HANDLING

    Storage: Store at controlled room temperature 68-77°F (20-25°C).

  • SPL UNCLASSIFIED SECTION

    Questions? Comments?

    To obtain product information including material safety data sheets (MSDS) or to report a suspected adverse reaction, call 1-800-441-8272.

    Distributed by:
    Intervet Inc (d/b/a Merck Animal Health)
    Madison, NJ 07940

    NADA #121-473, Approved by FDA

    Made in Austria

    www.Safe-Guard.com

  • PRINCIPAL DISPLAY PANEL - 3 Pouch Carton

    MERCK
    Animal Health

    safe-guard®
    (fenbendazole)

    Canine
    Dewormer

    For dogs only, 6 weeks and older.

    Drug Facts:
    Active ingredients (in each dosage unit): Fenbendazole Granules 22.2% (222 mg/g)

    Uses: For the treatment and control of:

    • Tapeworms
      (Taenia pisiformis)
    • Roundworms
      (Toxocara canis, Toxascaris leonina)
    • Hookworms
      (Ancylostoma caninum,
      Uncinaria stenocephala
      )
    • Whipworms
      (Trichuris vulpis)

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

    HUMAN WARNING:
    KEEP OUT OF REACH OF CHILDREN.

    PRINCIPAL DISPLAY PANEL - 3 Pouch Carton
  • INGREDIENTS AND APPEARANCE
    SAFE-GUARD 
    fenbendazole granule
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57926-483
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FENBENDAZOLE (UNII: 621BVT9M36) (FENBENDAZOLE - UNII:621BVT9M36) FENBENDAZOLE222 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57926-483-013 in 1 CARTON
    11 g in 1 POUCH
    2NDC:57926-483-023 in 1 CARTON
    22 g in 1 POUCH
    3NDC:57926-483-043 in 1 CARTON
    34 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA12147301/05/1979
    Labeler - Merck Sharp & Dohme Corp. (001317601)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.420823163API MANUFACTURE