VIRBANTEL- pyrantel pamoate/praziquantel tablet, chewable

Virbantel by

Drug Labeling and Warnings

Virbantel by is a Animal medication manufactured, distributed, or labeled by Virbac AH, Inc, Virbac Corporation, Legacy Pharmaceutical Packaging, Eurofins S-F Analytical Laboratories, Inc., Eurofins SF Analytical LLC, Cosma S.p.A, Megafine Pharma, Cipla, SEQUENT RESEARCH LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

INDICATIONS & USAGE

WARNINGS

Human Warning: Keep this and all medication out of the reach of children. To obtain produc tinformation, including a Material Safety Data Sheet (MSDS), 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.

SPL UNCLASSIFIED SECTION

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.

• 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.

NADA 141-261, Approved by FDA

Virbantel is a registered trademark
of Virbac S.A. © 2005

Package Principle Display Panel

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).

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

Virbac

Animal Health

Virbantel®

(pyrantel pamoate/praziquantel)

Flavored Chewables

De-wormer for Dogs Only

Medium and Large dogs -

25.1 to 200 lbs

Each chewable contains 114 mg pyrantel pamoate and 114 mg praziquantel

Virbac AH, Inc. Fort Worth, TX 76137

50 Flavored Chewables

NADA 141-261, Approved by FDA

Indications:For the treatment and control of roundworms (Toxocara canis, Toxascaris leonina), hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala), and tapeworms (Dipylidium caninum, Taenia pisiformis).

Dosage - Dog weight                               Number of Chewables
6.0 to 25 lbs . . . . . . . . . . . . . . . . . . . . . . Use the 30mg size
25.1 to 50 lbs . . . . . . . . . . . . . . . . . . . . . . . . . . 1
50.1 to 100 lbs. . . . . . . . . . . . . . . . . . . . . . . . . .2

100.1 to 150 lbs. . . . . . . . . . . . . . . . . . . . . . . . .3

150.1 to 200 lbs. . . . . . . . . . . . . . . . . . . . . . . . .4

For complete product information, see package insert.

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

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

Manufactured by:

Virbac AH, Inc. Fort Worth, TX 76137

LOT & EXPIRATION

INGREDIENTS AND APPEARANCE

VIRBANTEL 
pyrantel pamoate/praziquantel tablet, chewable

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 51311-741
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7)	PYRANTEL	114 mg
PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457)	PRAZIQUANTEL	114 mg

Product Characteristics
Color	brown	Score	2 pieces
Shape	ROUND	Size	14mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51311-741-10	1 in 1 BOX
1		50 in 1 BOTTLE

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	Business Operations
Virbac Corporation		829166276	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Cosma S.p.A		428655732	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Megafine Pharma		925627080	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Cipla		916940208	api manufacture