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FDA Approval

Tapeworm Dewormer for Cats

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Elanco US Inc.
DUNS: 966985624
Effective Date
May 21, 2025
Labeling Type
OTC ANIMAL DRUG LABEL
Praziquantel(23 mg in 1 1)

Products1

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

Tapeworm Dewormer for Cats

Product Details

NDC Product Code
58198-0063
Application Number
NADA111798
Marketing Category
NADA (C73593)
Route of Administration
ORAL
Effective Date
May 21, 2025
Code: 6490C9U457Class: ACTIBQuantity: 23 mg in 1 1

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel – 23 mg Bottle Label

Elanco

TAPEWORM
DEWORMER

(praziquantel tablets) FOR CATS

EACH TABLET CONTAINS:

23 mg praziquantel

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

Contents:
3
Tablets

Tapeworm Dewormer (praziquantel tablets) for cats Bottle Label


DESCRIPTION SECTION

DESCRIPTION:

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


INDICATIONS & USAGE SECTION

USES:

TAPEWORM DEWORMER (praziquantel tablets) will remove the common tapeworms, Dipylidium caninum and Taenia taeniaeformis, from cats and kittens.

DOSAGE & ADMINISTRATION SECTION

DOSAGE AND ADMINISTRATION:

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

*Not intended for use in kittens less than 6 weeks of age.

Body Weight (lbs)

No. of Tablets

4 pounds and under

½ tablet

5-11 pounds

1 tablet

Over 11 pounds

1 ½ tablets

FASTING IS NEITHER NECESSARY NOR RECOMMENDED.


WARNINGS SECTION

WARNING:

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


ADVERSE REACTIONS SECTION

SIDE EFFECTS:

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


HOW SUPPLIED SECTION

HOW SUPPLIED:

Bottle of 3 scored tablets. Each scored tablet contains 23 mg praziquantel.

STORAGE AND HANDLING SECTION

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

90208148_PA600248X

© 2022 Elanco or its affiliates


OTC - QUESTIONS SECTION

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.


SPL UNCLASSIFIED SECTION

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.


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