WORM PROTECTOR 2X CANINE ANTHELMINTIC- pyrantel pamoate suspension

Worm Protector 2X by

Drug Labeling and Warnings

Worm Protector 2X by is a Animal medication manufactured, distributed, or labeled by Huvepharma, Inc, Happy Jack Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

WORM PROTECTOR®2X
(pyrantel pamoate oral suspension)
Canine Anthelmintic Suspension

Active Ingredient: 4.54 mg of Pyrantel Base as Pyrantel Pamoate per mL
NOT FOR USE IN HUMANS
Approved by FDA under ANADA # 200-007
NET CONTENTS - fl. oz. (60 mL)

DOSAGE & ADMINISTRATION

IMPORTANT: SHAKE WELL BEFORE USING

DOSAGE AND ADMINISTRATION: Administer 1 teaspoon (5 mL) for each 10 lb of body weight. It is not necessary to withhold food prior to or after treatment. Dogs usually find this dewormer very palatable and will lick the dose from the bowl willingly. If there is reluctance to accept the
dose, mix in a small quantity of dog food to encourage consumption. It is recommended that dogs maintained under conditions of constant exposure to worm infestation should have a follow-up fecal exam within 2-4 weeks after treatment. For maximum control and prevention of reinfestation, it is recommended that puppies be treated at 2, 3, 4, 6, 8, and 10 weeks of age. Lactating bitches should be treated 2-3 weeks after whelping. Adult dogs kept in heavily contaminated quarters may be treated at monthly intervals to prevent T. canis reinfestation.

STORAGE AND HANDLING

RECOMMENDED STORAGE: STORE BELOW 86ºF (30ºC).
REV102025 | Item Number: 1792

PRODUCT LOT & EXPIRATION DATE PRINTED ON BOTTOM OF CONTAINER ▼

USER SAFETY WARNINGS

KEEP OUT OF REACH OF CHILDREN. Keep WORM PROTECTOR 2X in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

DESCRIPTION

WORM PROTECTOR®2X (pyrantel pamoate oral suspension)
Canine Anthelmintic Suspension

NOT FOR USE IN HUMANS
DESCRIPTION: WORM PROTECTOR 2X Liquid Wormer is a suspension of pyrantel pamoate in a palatable butterscotch flavored vehicle. Each mL contains 4.54 mg of pyrantel base as pyrantel pamoate.

Pyrantel pamoate is a compound belonging to a family classified chemically as tetrahydropyrimidines. It is a yellow, water-insoluble crystalline salt of the tetrahydropyrimidine base and pamoic acid containing 34.7% base activity. The chemical structure and name are given to the right:

SPL UNCLASSIFIED SECTION

INDICATIONS AND USAGE: WORM PROTECTOR 2X suspension is a highly palatable formulation intended as a single treatment for the removal of large roundworms (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala) in dogs and puppies. The presence of these parasites should be confirmed by laboratory fecal exam. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

WORM PROTECTOR 2X suspension may also be used to prevent reinfestation of T. canis in puppies and adult dogs and in lactating bitches after whelping.

GENERAL PRECAUTIONS

PRECAUTIONS: THIS PRODUCT IS A SUSPENSION AND AS SUCH WILL SEPARATE. TO ENSURE UNIFORM RESUSPENSION AND TO ACHIEVE
PROPER DOSAGE, IT IS EXTREMELY IMPORTANT THAT THE PRODUCT BE SHAKEN THOROUGHLY BEFORE EVERY USE.
KEEP OUT OF REACH OF CHILDREN

DOSAGE AND ADMINISTRATION: Administer 1 teaspoon (5 mL) for each 10 lb of body weight. It is not necessary to withhold food prior to or after treatment. Dogs usually find this dewormer very palatable and will lick the dose from the bowl willingly. If there is reluctance to accept the
dose, mix in a small quantity of dog food to encourage consumption. It is recommended that dogs maintained under conditions of constant exposure to worm infestation should have a follow-up fecal exam within 2-4 weeks after treatment. For maximum control and prevention of reinfestation, it is recommended that puppies be treated at 2, 3, 4, 6, 8, and 10 weeks of age. Lactating bitches should be treated 2-3 weeks after whelping. Adult dogs kept in heavily contaminated quarters may be treated at monthly intervals to prevent T. canis reinfestation.

For maximum control and prevention of reinfestation, it is recommended that puppies be treated at 2, 3, 4, 6, 8, and 10 weeks of age. Lactating bitches should be treated 2-3 weeks after whelping. Adult dogs kept in heavily contaminated quarters may be treated at monthly intervals to prevent T. canis reinfestation.

SUMMARY OF SAFETY AND EFFECTIVENESS

SAFETY AND EFFICACY STUDIES: Critical (worm count) studies in dogs demonstrated that pyrantel pamoate at the recommended dosage is highly efficacious against T. leonina (99%), T. canis (85%), A. caninum (97%), and U. stenocephala (94%).

One of the most outstanding and significant features of pyrantel pamoate is its wide margin of therapeutic safety in dogs. The acute oral LD(50) of pyrantel pamoate administered in gelatin capsules to female and male dogs is greater than 314 mg base per lb of body weight, which indicates a therapeutic index in excess of 138 times the recommended dosage. In subacute and chronic studies, no significant morphological abnormalities could be attributed to pyrantel pamoate when administered to dogs at daily dose rates up to 94 mg base per pound of body weight (40x) for periods of 19, 30, and 90 days. Clinical studies conducted in a wide variety of geographic locations using more than 40 different breeds of dogs showed no drug-induced toxic effects. Included in these studies were nursing pups, weaned pups, adults, pregnant bitches, and males at stud.

Additional data has demonstrated the safe use of pyrantel pamoate in dogs having heartworm infestations and/or receiving medication for heartworms, dogs exposed to organophosphate flea collars or flea/tick-dip treatments, and dogs undergoing concurrent treatment or medication at the time of worming such as immunization and antibacterial treatment.

STORAGE AND HANDLING

RECOMMENDED STORAGE: STORE BELOW 86° F (30° C). Keep WORM PROTECTOR 2X in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

HOW SUPPLIED

HOW SUPPLIED: WORM PROTECTOR 2X is supplied in 2 fl. oz. (60 mL), 8 fl. oz. (236 mL), and 16 fl. oz. (474 mL) bottles.

Approved by FDA under ANADA # 200-007

ADVERSE REACTIONS

Contact Information: To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Huvepharma, Inc. at 1-877-994-4883 or www.huvepharma.us. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WORM PROTECTOR 2X  CANINE ANTHELMINTIC
pyrantel pamoate suspension

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 23243-1450
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
pyrantel pamoate (UNII: 81BK194Z5M) (pyrantel - UNII:4QIH0N49E7)	pyrantel	4.54 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23243-1450-2	60 mL in 1 BOTTLE, PLASTIC
2	NDC: 23243-1450-8	236 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200007	11/20/2025

Labeler - Huvepharma, Inc (619153559)

Registrant - Happy Jack Inc (003189354)