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Animal NDC 23243-1450-8 Worm Protector 2x Canine Anthelmintic

Pyrantel Pamoate

Animal Product Information

Field Name Field Value
Animal NDC Code 23243-1450-8
Proprietary Name Worm Protector 2x Canine Anthelmintic 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 Pyrantel Pamoate 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 Huvepharma, Inc
Product Type Otc Animal Drug
Active Ingredient(s)
  • Pyrantel Pamoate
Marketing Category ANADA - ABBREVIATED 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 ANADA200007 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.

Worm Protector 2x Canine Anthelmintic Images

Worm Protector 2x Canine Anthelmintic 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



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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)

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.


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 86°F (30°C).
REV102025 | Item Number: 1792

PRODUCT LOT & EXPIRATION DATE PRINTED ON BOTTOM OF CONTAINER ▼

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.


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:


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.


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


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