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, Cosma S.p.A, Megafine Pharma, Cipla Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Human Warning:

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

Mfd. by: Virbac AH, Inc.

Fort Worth, TX 76137

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:

 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 the reach of children. To obtain product information, 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.

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

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.

NADA 141-261,
Approved by FDA

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

Package Principle Display Panel

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.

Mfd. by Virbac AH, Inc. Fort Worth, TX 76137

Virbac

Animal Health

Virbantel®

(pyrantel pamoate / praziquantel)
Flavored Chewables

De-wormer for Dogs Only
Small dogs and puppies - 6.0 to 25 lbs.

Each chewable contains 30 mg pyrantel pamoate and 30 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), tapeworms (Dipylidium caninum, Taenia pisiformis).

Dosage - Dog weight                 No. of Chewables
6.0 to 12 lbs . . . . . . . . . . . . . . . . . . . . . . 1
12.1 to 25 lbs . . . . . . . . . . . . . . . . . . . . . 2
More than 25 lbs . . . . . . . . . . .Use the 114 mg chewable

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.

Mfd. 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: 51311-738
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7)	PYRANTEL	30 mg
PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457)	PRAZIQUANTEL	30 mg

Product Characteristics
Color	brown	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51311-738-10	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 Limited		916940208	api manufacture