Label: NEMEX 2 NON-STERILE- pyrantel pamoate suspension

  • NDC Code(s): 61106-2394-1, 61106-2394-2
  • Packager: Pfizer Animal Health
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 08/10

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  • SPL UNCLASSIFIED SECTION

    FOR ANIMAL USE ONLY

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  • DESCRIPTION

    Nemex-2 is a suspension of pyrantel pamoate in a palatable caramel-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

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

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  • INDICATIONS AND USAGE

    Nemex-2 suspension is a highly palatable formulation intended as a single treatment 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.

    Nemex-2 suspension may also be used to prevent reinfestation of T. canis in puppies and adult dogs and in lactating bitches after whelping.

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  • PRECAUTIONS

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

    KEEP OUT OF REACH OF CHILDREN

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  • DOSAGE AND ADMINISTRATION

    Administer 1 teaspoon (5 mL) for each 10 lb of body weight. 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 2–4 weeks after 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 T. canis reinfestation.

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  • SAFETY AND EFFICACY STUDIES

    Critical (worm count) studies in dogs demonstrated that Nemex-2 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 Nemex-2 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 Nemex-2 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 Nemex-2 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.

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  • RECOMMENDED STORAGE

    Store below 30°C (86°F).

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  • HOW SUPPLIED

    Nemex-2 is supplied in 2 fl. oz. (60 mL) and 16 fl. oz. (473 mL) bottles.

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  • SPL UNCLASSIFIED SECTION

    NADA #100-237, Approved by FDA

    TAKE TIME OBSERVE LABEL DIRECTIONS

    Distributed by:
    Pfizer Animal Health
    Div. of Pfizer Inc
    NY, NY 10017

    10225300
    81551910
    February 2009

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  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

    NEMEX®-2
    (pyrantel pamoate)
    CANINE ANTHELMINTIC
    SUSPENSION

    Active Ingredient: 4.54 mg of
    pyrantel base as pyrantel pamoate per mL

    FOR ANIMAL USE ONLY

    2 FL OZ (60 mL)
    NADA #100-237, Approved by FDA

    PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    NEMEX 2   NON-STERILE
    pyrantel pamoate suspension
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:61106-2394
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    pyrantel pamoate (pyrantel) pyrantel 4.54 mg  in 1 mL
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CARAMEL Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61106-2394-1 60 mL in 1 BOTTLE
    2 NDC:61106-2394-2 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA100237 06/22/1979
    Labeler - Pfizer Animal Health (039055157)
    Establishment
    Name Address ID/FEI Business Operations
    Pfizer Animal Health 039055157 MANUFACTURE
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