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Animal NDC 58198-0056-1 Quad Dewormer

Praziquantel, Pyrantel Pamoate, Febantel

Animal Product Information

Field Name Field Value
Animal NDC Code 58198-0056-1
Proprietary Name Quad Dewormer What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Praziquantel, Pyrantel Pamoate, Febantel What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Elanco Us Inc.
Product Type Otc Animal Drug
Usage Information
    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.
Active Ingredient(s)
  • Praziquantel
  • Febantel
  • Pyrantel Pamoate
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA141007 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Quad Dewormer Images

Quad Dewormer Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



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:

Quad Dewormer Chewable Tablets for Dogs Dosage Charts
*NOT FOR USE IN PUPPIES LESS THAN 3 WEEKS OF AGE OR DOGS WEIGHING LESS THAN 2 LBS.

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 Elanco at 888-545-5973.


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

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

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

© 2022 Elanco or its affiliates.

Approved by FDA under NADA # 141-007

Patent information at http://www.elancopatents.com

Revised: March 2022
90208122_PA600245X

Elanco™


Principal Display Panel – Large Dogs Carton Label



Elanco

Quad Dewormer

(praziquantel/pyrantel pamoate/febantel)

Chewable Tablets for Dogs

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

Whipworm
Tapeworm
Hookworm
Roundworm

2 Chewable Tablets

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.


Principal Display Panel – Medium Dogs Carton Label



Elanco

Quad Dewormer

(praziquantel/pyrantel pamoate/febantel)

Chewable Tablets for Dogs

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

Whipworm
Tapeworm
Hookworm
Roundworm

2 Chewable Tablets

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.


Principal Display Panel – Puppies And Small Dogs Carton Label



Elanco

Quad Dewormer

(praziquantel/pyrantel pamoate/febantel)

Chewable Tablets for Dogs

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

Whipworm
Tapeworm
Hookworm
Roundworm

4 Chewable Tablets

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.


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.