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Animal NDC 57926-483-04 Safe-guard

Fenbendazole

Animal Product Information

Field Name Field Value
Animal NDC Code 57926-483-04
Proprietary Name Safe-guard What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Fenbendazole What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Merck Sharp & Dohme Corp.
Product Type Otc Animal Drug
Usage Information
    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.
Active Ingredient(s)
  • Fenbendazole
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA121473 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Safe-guard Images

Safe-guard Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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)
101 gram
11 to 20 2 gram
21 to 30

Combine pouches to obtain recommended daily dosage.

1 gram + 2 gram
31 to 40 4 gram
41 to 501 gram + 4 gram
51 to 602 gram + 4 gram
61 to 80Two 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.


Other



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.

    • 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.

    Questions? Comments?

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

    MERCK
    Animal Health

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

    Rev. 07/22

    Approved by FDA under NADA # 121-473

    Fenbendazole (active ingred.) made in: see imprint. Formulated in Austria.

    www.Safe-Guard.com


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).


Principal Display Panel - 3 Pouch Carton - 10 Lbs



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 - 20 Lbs



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 - 40 Lbs



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.


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.