Label: PRO-WORMER 2- pyrantel pamoate suspension 

  • NDC Code(s): 65713-303-02, 65713-303-16
  • Packager: Foster and Smith Inc
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated 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 07/13

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

  • ACTIVE INGREDIENT

    4.54 mg of Pyrantel Base as Pyrantel Pamoate per mL

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  • IMPORTANT

    SHAKE WELL BEFORE USE

    REFER TO PACKAGE INSERT FOR COMPLETE DIRECTIONS

    Barcode 25141 20270

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  • STORAGE

    Store at controlled room temperature between 15°- 30°C (59°- 86°F). Keep container tightly closed when not in use.

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  • FOR QUESTIONS OR TO REORDER

    1-800-562-7169
    DrsFosterSmith.com
    Manufactured for:
    Foster and Smith, Inc.
    2253 Air Park Road
    Rhinelander, WI 54501

    Item #30311 Iss. 05-12

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  • INDICATIONS

    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. PRO-Wormer•2® may also be used to prevent reinfestation of Toxocara canis in puppies and adult dogs andin lactating bitches after whelping.

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  • DIRECTIONS FOR USE

    Administer 1 full teaspoon (5 mL) for each 10 lb of body weight. To assure proper dosage, weigh animal prior to treatment. 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 first treatment. If your dog looks or acts sick, consult your veterinarian before 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 Toxocara canis reinfestation.

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  • SPL UNCLASSIFIED SECTION

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    DIRECTIONS

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  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

    DOCTORS
    FOSTERandSMITH

    PRO-Wormer•2
    (pyrantel pamoate)
    CANINE ANTHELMINTIC SUSPENSION

    Removes Large Roundworms
    and Hookworms

    For Animal Use Only Keep Out of Reach of Children

    ANADA 200-007, Approved by FDA

    Net Contents: 2 fl oz (60 mL)

    PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    PRO-WORMER 2 
    pyrantel pamoate suspension
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:65713-303
    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
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65713-303-02 60 mL in 1 BOTTLE, PLASTIC
    2 NDC:65713-303-16 473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200007 08/30/2012
    Labeler - Foster and Smith Inc (122135148)
    Registrant - Happy Jack Inc (003189354)
    Establishment
    Name Address ID/FEI Business Operations
    ABS Corporation 048022727 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    COSMA Spa 428655732 API MANUFACTURE
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