Quad Dewormer: Product Information

QUAD DEWORMER- praziquantel, pyrantel pamoate and febantel tablet, chewable
Elanco US Inc.

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. ofTablets
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. ofTablets
26-30 1.0
31 -44 1.5
45-60 2.0
for Large Dogs(45 lbs. and greater)
Body Wt.(lbs.) No. ofTablets
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 1-800-255-6826.

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

Elanco US Inc
Shawnee, KS 66216

© 2020 Elanco or its affiliates.

Approved by FDA under NADA # 141-007

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

November, 2020
90196985 LV2011

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
HookwormRoundworm

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 – Large Dogs Carton Label
(click image for full-size original)

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
HookwormRoundworm

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 – Medium Dogs Carton Label
(click image for full-size original)

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
HookwormRoundworm

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.

Principal Display Panel – Puppies and Small Dogs Carton Label
(click image for full-size original)
QUAD DEWORMER praziquantel, pyrantel pamoate, febantel tablet, chewable
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:58198-0056
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAZIQUANTEL (PRAZIQUANTEL) PRAZIQUANTEL 22.7 mg
PYRANTEL PAMOATE (PYRANTEL) PYRANTEL 22.7 mg
FEBANTEL (FEBANTEL) FEBANTEL 113.4 mg
Product Characteristics
Color brown (brown) Score 2 pieces
Shape FREEFORM (BONE) Size 20mm
Flavor MEAT (ARTIFICIAL BEEF) Imprint Code NADA141007
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58198-0056-2 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK (58198-0056-1)
1 NDC:58198-0056-1 4 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (58198-0056-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141007 12/09/2015
QUAD DEWORMER praziquantel, pyrantel pamoate, febantel tablet, chewable
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:58198-0057
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAZIQUANTEL (PRAZIQUANTEL) PRAZIQUANTEL 68 mg
PYRANTEL PAMOATE (PYRANTEL) PYRANTEL 68 mg
FEBANTEL (FEBANTEL) FEBANTEL 340.2 mg
Product Characteristics
Color brown (brown) Score 2 pieces
Shape FREEFORM (BONE) Size 25mm
Flavor MEAT (ARTIFICIAL BEEF) Imprint Code NADA141007
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58198-0057-2 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK (58198-0057-1)
1 NDC:58198-0057-1 2 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (58198-0057-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141007 12/09/2015
QUAD DEWORMER praziquantel, pyrantel pamoate, febantel tablet, chewable
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:58198-0058
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAZIQUANTEL (PRAZIQUANTEL) PRAZIQUANTEL 136 mg
PYRANTEL PAMOATE (PYRANTEL) PYRANTEL 136 mg
FEBANTEL (FEBANTEL) FEBANTEL 680.4 mg
Product Characteristics
Color brown (brown) Score 2 pieces
Shape FREEFORM (BONE) Size 32mm
Flavor MEAT (ARTIFICIAL BEEF) Imprint Code NADA141007
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58198-0058-2 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK (58198-0058-1)
1 NDC:58198-0058-1 2 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (58198-0058-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141007 12/09/2015
Labeler — Elanco US Inc. (966985624)
Establishment
Name Address ID/FEI Operations
Elanco US Inc. 117617385 MANUFACTURE, ANALYSIS, PACK, LABEL
Establishment
Name Address ID/FEI Operations
Merck KGaA 342249299 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
COSMA Spa 428655732 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
F.I.S. FABBRICA ITALIANA SINTETICI S.P.A. 437769315 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Ipca Laboratories Limited 862179827 API MANUFACTURE
Establishment
Name Address ID/FEI Operations
Hisun Pharmaceutical (Nantong) Co., Ltd. 421314476 API MANUFACTURE

Revised: 06/2021 Elanco US Inc.

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