Animal NDC 59051-6009-7 Pyrid 2x Canine Anthelmintic
Pyrantel Pamoate
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 59051-6009-7 |
| Proprietary Name | Pyrid 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 | Neogen Corporation-mercer |
| Product Type | Otc Animal Drug |
| Usage Information |
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| Active Ingredient(s) |
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| 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. |
Pyrid 2x Canine Anthelmintic Images
Pyrid 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
- Pyrid 2X(Pyrantel Pamoate Oral Suspension)Canine Anthelmintic Suspensiondescription & Indications And Usage Sections
- Precautions Section
- Dosage And Administration Section
- Safety And Efficacy Studies Section
- Storage And Handling Section
- Contact Information Section
- Package Label.Principal Display Panel
Pyrid 2X(Pyrantel Pamoate Oral Suspension)Canine Anthelmintic Suspensiondescription & Indications And Usage Sections
Pyrid 2x
(pyrantel pamoate oral suspension)
Canine Anthelmintic Suspension
NOT FOR USE IN HUMANS
DESCRIPTION: Pyrid 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 below:
INDICATIONS AND USAGE: Pyrid 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.
Pyrid 2x suspension may also be used to prevent reinfestation of T.canis in puppies and adult dogs
and in lactating bitches after whelping.
Precautions Section
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 Section
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.
Safety And Efficacy Studies Section
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 Section
RECOMMENDED STORAGE: STORE BELOW 86° F (30° C). Keep Pyrid 2x in a secure location out
of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.
HOW SUPPLIED: Pyrid 2x is supplied in 2 fl. oz. (60 mL), 16 fl. oz. (474 mL), and 32 fl. oz. (946 mL)
bottles.
Contact Information Section
Approved by FDA under ANADA # 200-007
Contact Information: To report suspected adverse events or for medical assistance
contact 1-800-498-5743. For technical assistance or to obtain a copy of the Safety Data Sheet(SDS), contact Neogen Corporation at 1-859-254-1221. For additional information aboutadverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS orhttp://www.fda.gov/reportanimalae
Manufactured for:Neogen Corporation620 Lesher PlaceLansing, MI 48912 USAprovectapet.com
For customer questions call 1-859-254-1221
For medical emergencies call 1-800-498-5743
Package Label.Principal Display Panel
Pyrid™ 2x
(pyrantel pamoate oral suspension)
Canine Anthelmintic Suspension
IMPORTANT: SHAKE WELL BEFORE USING
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 – 16 fl. oz. (474 mL)
PROVECTA®
Pyrid™ 2x
(pyrantel pamoate oral suspension)
Canine Anthelmintic Suspension
IMPORTANT: SHAKE WELL BEFORE USING
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 – 32 fl. oz. (946 mL)
PROVECTA®
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.
