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TAPEWORM DEWORMER FOR DOGS

™ Tapeworm Dewormer (praziquantel tablets) for dogs

Approved
Approval ID

94812721-1153-49f7-b574-ef4c24ebc70d

Product Type

OTC ANIMAL DRUG LABEL

Effective Date

May 21, 2025

Manufacturers
FDA

Elanco US Inc.

DUNS: 966985624

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

PRAZIQUANTEL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code58198-0064
Application NumberNADA111798
Product Classification
M
Marketing Category
C73593
G
Generic Name
PRAZIQUANTEL
Product Specifications
Route of AdministrationORAL
Effective DateMay 21, 2025
FDA Product Classification

INGREDIENTS (1)

PRAZIQUANTELActive
Quantity: 34 mg in 1 1
Code: 6490C9U457
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/21/2025

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

Tapeworm Dewormer (praziquantel tablets) for dogs Bottle Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/21/2025

USES:

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

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 5/21/2025

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.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/21/2025

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.

DESCRIPTION SECTION

LOINC: 34089-3Updated: 5/21/2025

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/21/2025

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.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/21/2025

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.

WARNINGS SECTION

LOINC: 34071-1Updated: 5/21/2025

WARNING:

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

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 5/21/2025

HOW SUPPLIED:

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/21/2025

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.

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TAPEWORM DEWORMER FOR DOGS - FDA Drug Approval Details