Animal NDC 54771-0459-1 Strongid 48

Pyrantel Tartrate

Animal Product Information

Field Name Field Value
Animal NDC Code 54771-0459-1
Proprietary Name Strongid 48 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 Tartrate 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 Zoetis Inc.
Product Type Otc Type A Medicated Article Animal Drug
Usage Information
    For the prevention of Strongylus vulgaris larval infestation in horses.For control of the following parasites in horses:Large Strongyles (adults): S. vulgaris, S. edentatusSmall Strongyles (adults and fourth-stage larvae): Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., Poteriostomum spp., Triodontophorus spp.Pinworms (adults and fourth-stage larvae): Oxyuris equiAscarids (adults and fourth-stage larvae): Parascaris equorum
Active Ingredient(s)
  • Pyrantel Tartrate
Marketing Category NADA - 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 NADA140819 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.

Strongid 48 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



Active Drug Ingredient:



Pyrantel tartrate.........................................10.6% (48 g/lb)


Indications For Use:



For the prevention of Strongylus vulgaris larval infestation in horses.

For control of the following parasites in horses:
Large Strongyles (adults): S. vulgaris, S. edentatus
Small Strongyles (adults and fourth-stage larvae): Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., Poteriostomum spp., Triodontophorus spp.
Pinworms (adults and fourth-stage larvae): Oxyuris equi
Ascarids (adults and fourth-stage larvae): Parascaris equorum


Caution:



CAUTION: For use in manufacturing of equine feeds only.

CAUTION: Certain components of animal feeds, including medicated premixes, possess properties that may be a potential health hazard or a source of personal discomfort to certain individuals who are exposed to them. Human exposure should, therefore, be minimized by observing the general industry standards for occupational health and safety.

Precautions such as the following should be considered: dust masks or respirators and protective clothing should be worn; dust-arresting equipment and adequate ventilation should be utilized; personal hygiene should be observed; wash before eating or leaving a work site; be alert for signs of allergic reactions—seek prompt medical treatment if such reactions are suspected.


Storage



STORE IN A DRY, COOL PLACE
SEE BACK PANEL FOR FURTHER USE DIRECTIONS


Mixing And Use Directions



Strongid is to be administered on a continuous basis either as a top-dress or mixed in the horse’s daily grain ration at the rate of 1.2 mg/lb (2.64 mg/kg) of body weight daily. The duration of administration is for the period during which the horse is at risk of exposure to internal parasites.

Foals may be treated at such time when consistent intake of grain mix is occurring. This is generally between 2 and 3 months of age. 

Strongid may be used in mares at any stage of pregnancy or lactation. Stallion fertility is not affected by the use of Strongid.

Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.

Typical Mixing Directions to Deliver 1.2 mg/lb (2.64 mg/kg)

lb of Medicated Grain Mix per 100 lb of Body Weightlb of Strongid 48lb of Nonmedicated FeedResulting Concentration (g/ton)
 2.002.51997.5120
1.53.31996.7160
0.5010.01990.0480
0.2025.01975.01200

lb of Medicated Top-Dress per 100 lb of Body Weightlb of Strongid 48lb of Nonmedicated FeedResulting Concentration (g/ton)
0.04125.01875.06000
0.025200.01800.09600
0.02250.01750.012000
0.0125400.01600.019200

Warning



Do not use in horses intended for human consumption.


Other Warnings



Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers. Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance. Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method). A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.


Caution



Consult your veterinarian before using in severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism. Do not mix in feeds containing bentonite.


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