Animal NDC 21091-716-01 Petarmor Sure Shot 2x

Table of Contents

• Information For Owners/Caregivers
• Indications For Use:
• Dosage And Administration:
• Storage And Handling
• Summary Of Safety And Effectiveness
• Other
• Principal Display Panel - 60 Ml Bottle Carton

Information For Owners/Caregivers

Canine Anthelmintic Suspension
Approved by FDA under ANADA # 200-007

Sure Shot^® 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.

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

Indications For Use:

Sure Shot^® 2X suspension is a highly palatable formulation intended as a single treatment for the removal of large roundworms (Toxocara canis and Toxacaris leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala) in dogs and puppies.

Sure Shot^® 2X suspension may also be used to prevent reinfestation of T. canis in puppies and adult dogs and in lactating bitches after whelping.

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

Dosage And Administration:

Administer one full teaspoon (5 mL) for each 10 pounds of body weight (2.27 mg base per lb. of body weight). Although most dogs have been observed to find this formulation very palatable and willingly consume it undiluted, it may be necessary to mix a small quantity of formulation in the dog's normal ration to encourage consumption. Fasting prior to and after treatment is not necessary.

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 T. canis reinfestation.

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

Storage And Handling

RECOMMENDED STORAGE: Store below 86°F (30°C).

Summary Of Safety And Effectiveness

Efficacy:

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

Safety:

One of the most outstanding and significant features of pyrantel pamoate 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 pound of body weight, which indicates a therapeutic index in excess of 138× 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 pound of body weight (40×) 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 (1) dogs having heartworm infections and/or receiving medication for heartworms, (2) dogs exposed to organophosphate flea collars or flea/tick dip treatments, and (3) dogs undergoing concurrent treatment or medication at the time of worming such as immunization and antibacterial treatment.

Other

Distributed by:
Sergeant's Pet Care Products, LLC, 10077 S. 134th Street, Omaha, NE 68138

P059662-2 AHIA

Principal Display Panel - 60 Ml Bottle Carton

PETARMOR^®
FOR DOGS

Sure Shot^® 2X
(pyrantel pamoate)

Canine Anthelmintic Suspension

Each 2 oz bottle treats

120 lbs

Removes Large
Roundworms and

Hookworms in

Puppies & Dogs

Active ingredient 4.54 mg of pyrantel

base as pyrantel pamoate per mL.

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

Approved by FDA under ANADA # 200-007

NET CONTENTS: 2 fl oz (60 mL)