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Animal NDC 51311-741-10 Virbantel

Pyrantel Pamoate/praziquantel

Animal Product Information

Field Name Field Value
Animal NDC Code 51311-741-10
Proprietary Name Virbantel 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 Pyrantel Pamoate/praziquantel 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 Virbac Ah, Inc
Product Type Otc Animal Drug
Usage Information
    Uses: For the treatment and control of:• Roundworms (Toxocara canis, Toxascaris leonina)• Hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala)• Tapeworms (Dipylidium caninum, Taenia pisiformis)
Active Ingredient(s)
  • Praziquantel
  • Pyrantel Pamoate
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 NADA141261 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.

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Virbantel 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



Virbantel® Flavored Chewables

Package contents: bottle of 50 flavored chewables


Drug Facts



Active Ingredients (in each chewable): pyrantel pamoate (114 mg) and praziquantel (114 mg)

Purpose: De-wormer for Medium and Large Dogs Only (Greater than 25 pounds)


Indications & Usage



Uses: For the treatment and control of:
• Roundworms (Toxocara canis, Toxascaris leonina)
• Hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala)
• Tapeworms (Dipylidium caninum, Taenia pisiformis)


When Using This Product:



• Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.
• Do not de-worm a dog or puppy that is sick. Consult a veterinarian for diagnosis of the illness.
• Virbantel Flavored Chewables are safe for use in puppies 12 weeks or older and adult dogs. Safety in breeding dogs and pregnant bitches has not been tested.


You May Notice:



Vomiting, loose stools (with or without blood) and decreased activity following treatment. If you notice these signs, contact a veterinarian.


Warnings



Human Warning: Keep this and all medication out of the reach of children. To obtain product information, including a Safety Data Sheet (SDS), call 1-800-338-3659.


Directions



Directions: Each flavored chewable contains 114 mg of pyrantel pamoate and 114 mg of praziquantel. The dose for each drug is 2.27 mg per pound of body weight (5 mg/kg). Please refer to the following dosing table for help finding the right dose for your dog.

Virbantel Flavored Chewables Dosing Table
 Dog Weight Number of Chewables
 6.0 to 25 pounds Use the 30mg size.
 25.1 to 50 pounds 1
 50.1 to 100 pounds 2 
 100.1 to 150 pounds 3
 150.1 to 200 pounds 4 
  • You should weigh your dog to make sure you are giving the right dose.
  • Virbantel Flavored Chewables are palatable if offered by hand. If your dog does not voluntarily eat the chewable, you can hide the chewable in a small amount of food or place it in the back of the dog's mouth for forced swallowing.
  • Make sure that the dog eats the complete dose.
  • Watch your dog for a few minutes after dosing to make sure the chewable is not rejected.

Other Information:



Recommended De-Worming Schedule:
Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. De-worming schedules may vary depending on the climate where you live and the activity of your dog.


Re-treatment: Re-treatment of your dog may be necessary as determined by laboratory fecal examination and/or if your dog is living where re-infections are likely to occur. Consult your veterinarian for assistance in the diagnosis and prevention of re-infection. In case of re-infection with tapeworms (Dipylidium caninum), consult your veterinarian for advice on how to remove fleas from the dog and the environment.


Manufactured By:



Virbac AH, Inc.
Fort Worth, TX 76137


Storage:



Store at controlled room temperature of 59-86˚F (15-30˚C).


Questions? Comments?



To report a suspected adverse reaction, call
1-800-338-3659.

2/2019 301799-03
Approved by FDA under NADA # 141-261

© 2019 Virbac Corporation. All Rights Reserved.

VIRBANTEL is a registered trademark of Virbac S.A.


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