K9 WORMBGONE 2X- pyrantel pamoate suspension 
First Companion Veterinary Products

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FOR ANIMAL USE ONLY

Pyrantel Pamoate-2X is a suspension of pyrantel pamoate in a palatable butterscotch-flavored vehicle. Each mL contains 4.54 mg of pyrantel base as pyrantel pamoate.

Pyrantel pamoate is a compound belonging to a family classified chemically as tetrahydropyrimidines. It is a yellow, water-insoluble crystalline salt of the tetrahydropyrimidine base and pamoic acid containing 34.7% base activity. The chemical structure and name are given below:

image of chemical structure for pyrantel pamoate

(E)-1,4,5,6-Tetrahydro-1-methyl-2-[2-(2-thienyl)vinyl] pyrimidine 4,4’ methylenebis [3-hydroxy-2-naphthoate] (1:1)

INDICATIONS:

For the removal of large roundworms (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala) in dogs and puppies. The presence of these parasites should be confirmed by laboratory fecal exam. Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism. Pyrantel Pamoate-2X may also be used to prevent reinfestation of Toxocara canis in puppies and adult dogs and in lactating bitches after whelping.

DIRECTIONS FOR USE:

Administer 1 full teaspoon (5 mL) for each 10 lb of body weight. To assure proper dosage, weigh animal prior to treatment. It is not necessary to withhold food prior to or after treatment. Dogs usually find this dewormer very palatable and will lick the dose from the bowl willingly. If there is reluctance to accept the dose, mix in a small quantity of dog food to encourage consumption. It is recommended that dogs maintained under conditions of constant exposure to worm infestation should have a follow-up fecal exam within 2 to 4 weeks after first treatment. If your dog looks or acts sick, consult your veterinarian before treatment. For maximum control and prevention of reinfestation, it is recommended that puppies be treated at 2, 3, 4, 6, 8 and 10 weeks of age. Lactating bitches should be treated 2-3 weeks after whelping. Adult dogs kept in heavily contaminated quarters may be treated at monthly intervals to prevent Toxocara canis reinfestation.

CAUTION:

THIS PRODUCT IS A SUSPENSION AND AS SUCH WILL SEPARATE. TO INSURE UNIFORM RE-SUSPENSION AND TO ACHIEVE PROPER DOSAGE, IT IS EXTREMELY IMPORTANT THAT THE PRODUCT BE SHAKEN THOROUGHLY BEFORE EVERY USE.

STORAGE:

Store at room temperaturebetween 15°-30°C (59°-86°F).

SAFETY AND EFFICACY:

Critical (worm count) studies in dogs demonstrated that Pyrantel Pamoate-2X at the recommended dosage is highly efficacious against T. leonina (99%), T. canis (85%), A. caninum (97%), and U. stenocephala (94%).

One of the most outstanding and significant features of Pyrantel Pamoate-2X is its wide margin of therapeutic safety in dogs. The acute oral LD50 of pyrantel pamoate administered in gelatin capsules to female and male dogs is greater than 314 mg base per lb of body weight, which indicates a therapeutic index in excess of 138 times the recommended dosage. In subacute and chronic studies, no significant morphological abnormalities could be attributed to pyrantel pamoate when administered to dogs at daily dose rates up to 94 mg base per lb of body weight (40x) for periods of 19, 30, and 90 days. Clinical studies conducted in a wide variety of geographic locations using more than 40 different breeds of dogs showed no drug-induced toxic effects. Included in these studies were nursing pups, weaned pups, adults, pregnant bitches, and males at stud. Additional data have demonstrated the safe use of pyrantel pamoate in dogs having heartworm infestations and/or receiving medication for heartworms, dogs exposed to organophosphate flea collars or flea/tick dip treatments, and dogs undergoing concurrent treatment or medication at the time of worming such as immunization and antibacterial treatment.

PRESENTATION:

2 fl oz (60 mL), 4 fl oz (120 mL), 8 fl oz (240 mL) and 16 fl oz (473 mL) bottles.


KEEP OUT OF REACH OF CHILDREN

Rev. 01-05

ANADA 200-352, Approved by FDA

Manufactured By:

FIRST PRIORITY, INC.

Elgin, IL 60123-1146

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K9 WORMBGONE 2X 
pyrantel suspension
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:64556-315
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRANTEL PAMOATE (PYRANTEL) PYRANTEL4.54 mg  in 1 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorBUTTERSCOTCHImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:64556-315-0212 in 1 CASE
11 in 1 CARTON
160 mL in 1 BOTTLE, PLASTIC
2NDC:64556-315-1612 in 1 CASE
2473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20035207/15/200809/17/2013
Labeler - First Companion Veterinary Products (059580480)
Establishment
NameAddressID/FEIBusiness Operations
FIRST PRIORITY INCORPORATED179925722manufacture

Revised: 09/2013
 
First Companion Veterinary Products