Label: PETARMOR SURE SHOT 2X- pyrantel pamoate liquid

  • NDC Code(s): 21091-716-01
  • Packager: Sergeant's Pet Care Products, LLC
  • Category: OTC ANIMAL DRUG LABEL

Drug Label Information

Updated November 4, 2021

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  • 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.

    Chemical Structure

    Chemical Structure

    (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.

  • SPL UNCLASSIFIED SECTION

    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)

    Principal Display Panel - 60 mL Bottle Carton

    Principal Display Panel - 60 mL Bottle Carton

    Principal Display Panel - 60 mL Bottle Carton

  • INGREDIENTS AND APPEARANCE
    PETARMOR SURE SHOT 2X 
    pyrantel pamoate liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:21091-716
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrantel Pamoate (UNII: 81BK194Z5M) (Pyrantel - UNII:4QIH0N49E7) Pyrantel4.54 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Methylparaben Sodium (UNII: CR6K9C2NHK)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUTTERSCOTCHImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21091-716-011 in 1 CARTON
    160 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20000710/30/1996
    Labeler - Sergeant's Pet Care Products, LLC (876995171)
    Registrant - Happy Jack (003189354)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABS Corporation048022727MANUFACTURE, LABEL, PACK
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosma Spa428655732api manufacture