Label: WORM PROTECTOR 2X CANINE ANTHELMINTIC- pyrantel pamoate suspension

  • NDC Code(s): 58909-145-02, 58909-145-08
  • Packager: ProLabs Ltd
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated July 24, 2013

If you are a consumer or patient please visit this version.

  • IMPORTANT

    SHAKE WELL BEFORE USE

  • DIRECTIONS FOR USE

    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. Administer one full teaspoonful (5 mL) for each 10 lbs. of body weight.

    For the removal of large roundworms (ascarids) and hookworms. Administer one full teaspoonful (5 mL) for each 10 lbs. of body weight. It is not necessary to withhold food prior to treatment.

    If medication is to be dispensed, client can be advised that dogs usually find this wormer 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.

    The presence of these parasites should be confirmed by laboratory fecal examination. Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.

  • INDICATIONS FOR USE

    To prevent reinfestation of Toxocara canis in puppies and adult dogs and in lactating bitches after whelping.

    For the removal of large roundworms (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala) in dogs and puppies.

  • WARNING

    KEEP OUT OF REACH OF CHILDREN

    Read Accompanying Professional Information

  • HOW SUPPLIED

    RECOMMENDED STORAGE

    Store below 30°C (86°F)

    LOT/EXP:

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED FOR:
    ProLabs Ltd.
    P.O. Box 3103
    St. Joseph, MO 64503
    1-800-367-6359
    ProLabspets.com

    REV 0712

  • SAFE HANDLING WARNING

    Take Time: Observe
    Label Directions

  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

    ProLabs
    for HEALTHY PETS

    Worm
    Protector 2X
    [pyrantel pamoate]

    Canine Anthelmintic Suspension

    Active Ingredient: 4.54 mg of
    Pyrantel Base as Pyrantel Pamoate per mL
    Net Contents – 2 fl oz (60 mL)
    FOR ANIMAL USE ONLY
    ANADA 200-007 Approved by FDA

    PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    WORM PROTECTOR 2X   CANINE ANTHELMINTIC
    pyrantel pamoate suspension
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:58909-145
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    pyrantel pamoate (UNII: 81BK194Z5M) (pyrantel - UNII:4QIH0N49E7) pyrantel4.54 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58909-145-0260 mL in 1 BOTTLE, PLASTIC
    2NDC:58909-145-08237 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20000710/01/2012
    Labeler - ProLabs Ltd (962129602)
    Registrant - Happy Jack Inc (003189354)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABS Corporation048022727MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMA Spa428655732API MANUFACTURE