Label: TAPEWORM DEWORMER FOR DOGS- praziquantel tablet

  • NDC Code(s): 58198-0064-1, 58198-0064-2
  • Packager: Elanco US Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated October 24, 2022

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

  • SPL UNCLASSIFIED SECTION

    Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism. Consult your veterinarian before administering the tablets to weak or debilitated animals.

    Each tablet contains 34 mg praziquantel.

  • DESCRIPTION:

    Tapeworm Dewormer (praziquantel tablets) are sized for easy oral administration to either adult dogs or puppies. The tablets may be crumbled and mixed with the feed.

  • USES:

    Tapeworm Dewormer (praziquantel tablets) will remove the common tapeworms, Dipylidium caninum and Taenia pisiformis, from dogs and puppies.

  • DOSAGE AND ADMINISTRATION:

    Tapeworm Dewormer (praziquantel tablets) may be given directly in the mouth or crumbled and mixed with the food. Administer to dogs and puppies* only as follows:

    *Not intended for use in puppies less than 4 weeks of age.

    Body Weight (lbs)

    No. of Tablets

               5 lbs. and under

    ½ tablet

          6-10 lbs.

    1 tablet

        11-15 lbs.

    1½ tablets

        16-30 lbs.

    2 tablets

        31-45 lbs.

    3 tablets

        46-60 lbs.

    4 tablets

    Over 60 lbs.

    5 tablets maximum

    FASTING IS NEITHER NECESSARY NOR RECOMMENDED.

  • RETREATMENT:

    Steps should be taken to control fleas and rodents on the premises in order to prevent reinfection; otherwise, retreatment will be necessary. This is especially true in cases of tapeworms transmitted by fleas (Dipylidium caninum) where reinfection is almost certain to occur if fleas are not removed from the animal and its environment. If reinfection occurs, tapeworm segments may be observed within one month of the initial treatment.

  • SIDE EFFECTS:

    Isolated incident of either salivation, vomiting, diarrhea, poor appetite or listlessness have been reported following treatment, but were considered non-significant. If these signs are observed and they persist, consult your veterinarian.

  • Questions?

    For product questions, to report side effects, or for a copy of the Safety Data Sheet (SDS), call Elanco Product & Veterinary Support at 888-545-5973.

    For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

  • WARNING:

    Keep out of the reach of children. Not for human use.

  • HOW SUPPLIED:

    Bottle of 5 scored tablets. Each scored tablet contains 34 mg praziquantel.

  • STORAGE CONDITIONS:

    Store at less than or equal to 25°C (77°F).

    Elanco

    Manufactured for:
    Elanco US Inc.
    Greenfield, IN 46140 U.S.A.

    Approved by FDA under NADA # 111-798

    Elanco and the diagonal bar logo are trademarks of Elanco or
    its affiliates.

    Made in China                          Revised: March 2022

    90208154_PA600249X

    © 2022 Elanco or its affiliates.

  • Principal Display Panel - 34 mg Carton Label

    Elanco

    TAPEWORM
    DEWORMER
    (praziquantel tablets)
    for dogs

    Tapeworm tablets for dogs

    EACH TABLET CONTAINS:
    34 mg praziquantel

    WARNING: KEEP OUT OF REACH OF
    CHILDREN. NOT FOR HUMAN USE.

    5
    Tablets

    34mg Carton label
  • Principal Display Panel

    Elanco

    TAPEWORM
    DEWORMER
    (praziquantel tablets) FOR DOGS

    EACH TABLET CONTAINS:
    34 mg praziquantel

    WARNING: KEEP OUT OF REACH OF
    CHILDREN. NOT FOR HUMAN USE.

    Contents:
    5

    Tablets

    3 Tablet bottle label
  • INGREDIENTS AND APPEARANCE
    TAPEWORM DEWORMER FOR DOGS 
    praziquantel tablet
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:58198-0064
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457) PRAZIQUANTEL34 mg
    Product Characteristics
    Colorwhite (white) Score2 pieces
    ShapeROUND (ROUND) Size13mm
    FlavorImprint Code 34
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58198-0064-11 in 1 CARTON
    1NDC:58198-0064-25 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA11179805/16/2014
    Labeler - Elanco US Inc. (966985624)
    Establishment
    NameAddressID/FEIBusiness Operations
    TriRx Shawnee LLC118187894MANUFACTURE, ANALYSIS, PACK, LABEL
    Establishment
    NameAddressID/FEIBusiness Operations
    Merck KG auf Aktien342249299API MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Hisun Pharmaceutical (Nantong) Co., Ltd.421314476API MANUFACTURE