VIRBANTEL (PYRANTEL PAMOATE/PRAZIQUANTEL) TABLET, CHEWABLE [VIRBAC AH, INC]

VIRBANTEL (PYRANTEL PAMOATE/PRAZIQUANTEL) TABLET, CHEWABLE [VIRBAC AH, INC]
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NDC 51311-738-10
Set ID b79ee411-061a-4c89-8599-72629ba00ac5
Category OTC ANIMAL DRUG LABEL
Packager Virbac AH, Inc
Generic Name
Product Class
Product Number
Application Number NADA141261
  • Human Warning:

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

    301796 - 03

  • SPL UNCLASSIFIED SECTION

    Virbantel®
    Flavored
    Chewables
    Package contents: bottle of 50 flavored chewables

    Drug Facts
    Active Ingredients (in each chewable): pyrantel pamoate (30 mg) and praziquantel (30 mg)

  • Purpose:

    De-wormer for Small Dogs and Puppies Only (6.0 to 25 pounds).

  • Uses:

    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)
  • Human Warning:

    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.

  • 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.

  • Directions:

    Each flavored chewable contains 30 mg of pyrantel pamoate and 30 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 12 pounds:

    1 Chewable

    12.1 to 25 pounds:

    2 Chewables

    More than 25 pounds:

    Use 114 mg size

    • 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.

    02/19 301798 - 03

    Approved by FDA under NADA # 141-261

    ©2019 Virbac Corporation.
    All Rights Reserved.
    VIRBANTEL is a registered
    trademark of Virbac S.A.

  • Package Principle Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    VIRBANTEL 
    pyrantel pamoate/praziquantel tablet, chewable
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:51311-738
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7) PYRANTEL30 mg
    PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457) PRAZIQUANTEL30 mg
    Product Characteristics
    ColorbrownScore2 pieces
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51311-738-101 in 1 BOX
    150 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14126109/03/2007
    Labeler - Virbac AH, Inc (131568396)
    Registrant - Virbac AH, Inc (131568396)
    Establishment
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