PETARMOR SURE SHOT 2X- pyrantel pamoate liquid

PetArmor Sure Shot 2X by

Drug Labeling and Warnings

PetArmor Sure Shot 2X by is a Animal medication manufactured, distributed, or labeled by Sergeant's Pet Care Products, Inc., Happy Jack, ABS Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INFORMATION FOR OWNERS/CAREGIVERS

Canine anthelmintic suspension
ANADA #200-007, Approved by FDA

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 Toxocara 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.

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

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.

SPL UNCLASSIFIED SECTION

Distributed by:
Sergeant's Pet Care Products, Inc., Omaha, NE 68138
Visit us at: www.petarmor.com

P059330 ADRH

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

PETARMOR®
FOR DOGS

Sure Shot® 2X
(pyrantel pamoate)

Canine Anthelmintic Suspension

For puppies and dogs
up to 120 lbs

Removes
hookworms
(Ancylostoma caninum,
Uncinaria stenocephala)
and large
roundworms
(Ascarids)

Active ingredient 4.54 mg of
pyrantel base as pyrantel
pamoate per mL.

ANADA 200-007
Approved by FDA

Liquid Wormer

FOR ANIMAL USE ONLY
KEEP OUT OF REACH OF CHILDREN

NET CONTENTS: 2 fl oz (60 mL)

INGREDIENTS AND APPEARANCE

PETARMOR SURE SHOT 2X 
pyrantel pamoate liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 21091-716
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrantel Pamoate (UNII: 81BK194Z5M) (Pyrantel - UNII:4QIH0N49E7)	Pyrantel	4.54 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Methylparaben Sodium (UNII: CR6K9C2NHK)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUTTERSCOTCH	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21091-716-01	1 in 1 CARTON
1		60 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200007	10/30/1996

Labeler - Sergeant's Pet Care Products, Inc. (876995171)

Registrant - Happy Jack (003189354)

Establishment
Name	Address	ID/FEI	Business Operations
ABS Corporation		048022727	MANUFACTURE, LABEL, PACK