Virbantel: Product Information

VIRBANTEL- pyrantel pamoate and praziquantel tablet, chewable
Virbac AH, Inc

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

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
(click image for full-size original)

VIRBANTEL
pyrantel pamoate/praziquantel tablet, chewable
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:51311-738
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRANTEL PAMOATE (PYRANTEL) PYRANTEL 30 mg
PRAZIQUANTEL (PRAZIQUANTEL) PRAZIQUANTEL 30 mg
Product Characteristics
Color brown Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51311-738-10 1 BOTTLE in 1 BOX contains a BOTTLE
1 50 TABLET, CHEWABLE in 1 BOTTLE This package is contained within the BOX (51311-738-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141261 09/03/2007
Labeler — Virbac AH, Inc (131568396)
Registrant — Virbac AH, Inc (131568396)
Establishment
Name Address ID/FEI Operations
Virbac Corporation 829166276 manufacture
Establishment
Name Address ID/FEI Operations
Cosma S.p.A 428655732 api manufacture
Establishment
Name Address ID/FEI Operations
Legacy Pharmaceutical Packaging 143213275 pack
Establishment
Name Address ID/FEI Operations
Eurofins S-F Analytical Laboratories, Inc. 943863030 analysis
Establishment
Name Address ID/FEI Operations
Eurofins SF Analytical LLC 081266581 analysis
Establishment
Name Address ID/FEI Operations
SEQUENT RESEARCH LIMITED 676159446 analysis
Establishment
Name Address ID/FEI Operations
Megafine Pharma 925627080 api manufacture
Establishment
Name Address ID/FEI Operations
Cipla 916940208 api manufacture
Establishment
Name Address ID/FEI Operations
Alivira Animal Health Limited 650916617 api manufacture

Revised: 07/2021 Virbac AH, Inc

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