QUAD DEWORMER ((FEBANTEL, PRAZIQUANTEL, PYRANTEL PAMOATE)) TABLET, CHEWABLE [BAYER HEALTHCARE, LLC ANIMAL HEALTH DIVISION]

QUAD DEWORMER ((FEBANTEL, PRAZIQUANTEL, PYRANTEL PAMOATE)) TABLET, CHEWABLE [BAYER HEALTHCARE, LLC ANIMAL HEALTH DIVISION]
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NDC 0859-2407-01, 0859-2407-02, 0859-2408-01, 0859-2408-02, 0859-2409-01, 0859-2409-02
Set ID 1ddb6a09-f77e-4fd9-9f98-f4c20068c16e
Category OTC ANIMAL DRUG LABEL
Packager Bayer HealthCare, LLC Animal Health Division
Generic Name
Product Class
Product Number
Application Number NADA141007
  • QUAD DEWORMER (praziquantel/pyrantel pamoate/febantel) CHEWABLE TABLETS FOR DOGS

    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. Do not deworm a dog or puppy that is sick. Consult your veterinarian for diagnosis of the illness and appropriate care.

    Each Quad Dewormer Chewable Tablets for Puppies and Small Dogs contains 22.7 mg praziquantel, 22.7 mg pyrantel base as pyrantel pamoate and 113.4 mg febantel.

    Each Quad Dewormer Chewable Tablets for Medium Dogs contains 68.0 mg praziquantel, 68.0 mg pyrantel base as pyrantel pamoate and 340.2 mg febantel.

    Each Quad Dewormer Chewable Tablets for Large Dogs contains 136.0 mg praziquantel, 136.0 mg pyrantel base as pyrantel pamoate, and 680.4 mg febantel.

  • DESCRIPTION:

    Quad Dewormer (praziquantel/pyrantel pamoate/febantel) Chewable Tablets for Dogs are available in three tablet sizes. Each size is scored for convenient oral administration.

  • USES:

    Quad Dewormer (praziquantel/pyrantel pamoate/febantel) Chewable Tablets for Dogs will remove the common tapeworms, Dipylidium caninum and Taenia pisiformis, remove common hookworms, Ancylostoma caninum and Uncinaria stenocephala, remove common roundworms, Toxocara canis and Toxascaris leonina, and remove whipworms, Trichuris vulpis in dogs.

  • WARNING:

    KEEP OUT OF REACH OF CHILDREN.

  • USE DIRECTIONS

  • DOSAGE AND ADMINISTRATION:

    Quad Dewormer Chewable Tablets for Dogs may be given directly in the mouth or offered in a small amount of food. You should weigh your dog to make sure you are using the right size and number of tablets. Administer to dogs and puppies* only as follows:

    *
    NOT FOR USE IN PUPPIES LESS THAN 3 WEEKS OF AGE OR DOGS WEIGHING LESS THAN 2 LBS.

    Quad Dewormer

    Chewable Tablets for Dogs Dosage Charts

    for Puppies and Small Dogs*

    (2 - 25 lbs.)

    Body Wt.

    (lbs.)

    No. of

    Tablets

    2 - 4

    0.5

    5 - 7

    1.0

    8 - 12

    1.5

    13 - 18

    2.0

    19 - 25

    2.5

    for Medium Dogs

    (26 - 60 lbs.)

    Body Wt.

    (lbs.)

    No. of

    Tablets

    26 - 30

    1.0

    31 - 44

    1.5

    45 - 60

    2.0

    for Large Dogs

    (45 lbs. and greater)

    Body Wt.

    (lbs.)

    No. of

    Tablets

    45 - 60

    1.0

    61 - 90

    1.5

    91 - 120

    2.0

    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 vomiting, bloody stool or watery/profuse stool have been reported following treatment. If these signs are observed and they persist, consult your veterinarian.

    Questions? For questions or to report a suspected side effect, call Bayer at 1-855-886-7971.

  • STORAGE CONDITIONS:

    Store at or below 77 °F (25 °C).

    Un-blistered whole or partial tablets should be stored in a tightly sealed container.

  • HOW SUPPLIED:

    Quad Dewormer Chewable Tablets for Dogs are available in three tablet sizes:

    4 tabs/box for Puppies and Small Dogs
    2 tabs/box for Medium Dogs
    2 tabs /box for Large Dogs

    U.S. Patent No. 7,348,027

    ©2016 Bayer HealthCare LLC, Animal Health Division
    Shawnee Mission, Kansas
    Bayer and the Bayer Cross are registered trademarks of Bayer.
    85318950 V-06-2016
    NADA 141-007, Approved by FDA

  • Principal Display Panel – puppies and small dogs (2-25 lbs)

    Quad Dewormer (praziquantel/pyrantel pamoate/febantel) Chewable Tablets for Dogs label - puppies and small dogs (2-25 lbs)

    puppies and small dogs (2-25 lbs)

    QUAD DEWORMER
    (praziquantel/pyrantel pamoate/febantel)
    CHEWABLE TABLETS FOR DOGS

    Broad Spectrum Chewable
    Anthelmintic for Puppies and
    Small Dogs (2-25 lbs)

    EACH TABLET CONTAINS:
    22.7 mg praziquantel, 22.7 mg pyrantel base as pyrantel pamoate, and 113.4 mg febantel

    WARNING: KEEP OUT OF REACH OF CHILDREN.

    CONTENTS:

    4 Chewable Tablets

  • Principal Display Panel – medium dogs (26-60 lbs)

    Quad Dewormer (praziquantel/pyrantel pamoate/febantel) Chewable Tablets for Dogs label - medium dogs (26-60 lbs)

    medium dogs (26-60 lbs)

    QUAD DEWORMER
    (praziquantel/pyrantel pamoate/febantel)
    CHEWABLE TABLETS FOR DOGS

    Broad Spectrum Chewable
    Anthelmintic for Medium
    Sized Dogs (26-60 lbs)

    EACH TABLET CONTAINS:

    68.0 mg praziquantel, 68.0 mg pyrantel base as pyrantel pamoate, and 340.2 mg febantel

    WARNING: KEEP OUT OF REACH OF CHILDREN.

    CONTENTS:

    2 Chewable Tablets

  • Principal Display Panel – large dogs (45 lbs and greater)

    Quad Dewormer (praziquantel/pyrantel pamoate/febantel) Chewable Tablets for Dogs label - large dogs (45 lbs and greater)

    large dogs (45 lbs and greater)

    QUAD DEWORMER
    (praziquantel/pyrantel pamoate/febantel)
    CHEWABLE TABLETS FOR DOGS

    Broad Spectrum Chewable
    Anthelmintic for Large Sized Dogs
    (45 lbs and greater)

    EACH TABLET CONTAINS:
    136.0 mg praziquantel, 136.0 mg pyrantel base as pyrantel pamoate, and 680.4 mg febantel

    WARNING: KEEP OUT OF REACH OF CHILDREN.

    CONTENTS:

    2 Chewable Tablets

  • INGREDIENTS AND APPEARANCE
    QUAD DEWORMER 
    (febantel, praziquantel, pyrantel pamoate) tablet, chewable
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:0859-2407
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457) PRAZIQUANTEL22.7 mg
    PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7) PYRANTEL22.7 mg
    FEBANTEL (UNII: S75C401OS1) (FEBANTEL - UNII:S75C401OS1) FEBANTEL113.4 mg
    Product Characteristics
    ColorBROWNScore2 pieces
    ShapeFREEFORM (BONE) Size20mm
    FlavorMEAT (ARTIFICIAL BEEF) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0859-2407-021 in 1 CARTON
    1NDC:0859-2407-014 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14100712/09/2015
    QUAD DEWORMER 
    (febantel, praziquantel, pyrantel pamoate) tablet, chewable
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:0859-2408
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457) PRAZIQUANTEL68 mg
    PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7) PYRANTEL68 mg
    FEBANTEL (UNII: S75C401OS1) (FEBANTEL - UNII:S75C401OS1) FEBANTEL340.2 mg
    Product Characteristics
    ColorBROWNScore2 pieces
    ShapeFREEFORM (BONE) Size25mm
    FlavorMEAT (ARTIFICIAL BEEF) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0859-2408-021 in 1 CARTON
    1NDC:0859-2408-012 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14100712/09/2015
    QUAD DEWORMER 
    (febantel, praziquantel, pyrantel pamoate) tablet, chewable
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:0859-2409
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457) PRAZIQUANTEL136 mg
    PYRANTEL PAMOATE (UNII: 81BK194Z5M) (PYRANTEL - UNII:4QIH0N49E7) PYRANTEL136 mg
    FEBANTEL (UNII: S75C401OS1) (FEBANTEL - UNII:S75C401OS1) FEBANTEL680.4 mg
    Product Characteristics
    ColorBROWNScore2 pieces
    ShapeFREEFORM (BONE) Size32mm
    FlavorMEAT (ARTIFICIAL BEEF) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0859-2409-021 in 1 CARTON
    1NDC:0859-2409-012 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14100712/09/2015
    Labeler - Bayer HealthCare, LLC Animal Health Division (152266193)

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