Animal NDC 57926-480-04 Panacur C Canine

Fenbendazole

Animal Product Information

Field Name Field Value
Animal NDC Code 57926-480-04
Proprietary Name Panacur C Canine 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
    Uses: For the treatment and control of Roundworms (Toxocara canis, Toxascaris leonina), Hookworms (Ancylostoma caninum, Uncinaria stenocephala), Whipworms (Trichuris vulpis), and Tapeworms (Taenia pisiformis).
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.

Panacur C Canine 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



Other



Drug Facts

Other Information:

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

Recommended Deworming Schedule:

Deworming schedules may vary depending on the climate where you live and the activity of your dog. The following schedule should be used as general guidance. Newly weaned pups (6 to 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 six months of age should be dewormed at least twice each year. Each deworming requires 3 daily treatments. (See Directions)

Manufactured by:
Intervet GesmbH
Vienna, Austria

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

Approved by FDA under NADA # 121-473
Rev. 07/22
446500-C
Net Weight: 3 grams

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


Otc - Active Ingredient



Active ingredients (in each dosage unit):

Fenbendazole Granules 22.2% (222 mg/g)


Otc - Purpose



Purpose: Dewormer for Dogs Only


Indications & Usage



Uses: For the treatment and control of Roundworms (Toxocara canis, Toxascaris leonina), Hookworms (Ancylostoma caninum, Uncinaria stenocephala), Whipworms (Trichuris vulpis), and Tapeworms (Taenia pisiformis).


Warnings



Human Warning: Keep this and all medication out of the reach of children.


Adverse Reactions



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


Otc - When Using



When using this product: Panacur® C 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.


Dosage & Administration



Directions:

The daily dose for Panacur® C is 50 mg/kg (22.7 mg/lb) of body weight. Please refer to the following dosing table for help in finding the right dose for your dog.

Dosing Table
Dog WeightPacket Size

Packet size is the daily dose. The dog must be treated with this dose for 3 days in a row.

10 pounds1 gram
20 pounds2 gram
30 pounds1 gram + 2 gram
40 pounds4 gram
50 pounds1 gram + 4 gram
60 pounds2 gram + 4 gram
80 poundsTwo 4 gram
Over 80 poundsUse combinations to obtain recommended daily dose.
  • You should weigh your dog to make sure you are using the right size and number of packets. If your dog's weight is in-between the suggested dosing sizes, it is safe to use the next higher size. For example, a 15-pound dog should be treated with the 2-gram packet.
  • Give Panacur® C to your dog by mixing the daily dose with a small amount of the usual food. Make sure your dog eats all of the medicated food. You may need to moisten dry dog food to aid mixing.
  • Repeat the daily dose for three days in a row.

Storage And Handling



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


Otc - Questions



Questions? Comments?

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


Principal Display Panel - 1 G Packet Carton



MERCK
Animal Health

panacur® c
(fenbendazole)

Canine
Dewormer

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


Principal Display Panel - 2 G Packet Carton



MERCK
Animal Health

panacur® c
(fenbendazole)

Canine
Dewormer

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


Principal Display Panel - 4 G Packet Carton



MERCK
Animal Health

panacur® c
(fenbendazole)

Canine
Dewormer

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


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