Animal NDC 66104-2391-1 Banminth 48

Pyrantel Tartrate

Animal Product Information

Field Name Field Value
Animal NDC Code 66104-2391-1
Proprietary Name Banminth 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 Phibro Animal Health
Product Type Otc Type A Medicated Article Animal Drug
Usage Information
    For the removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum)infections in swine. Aid in the prevention of migration and establishment of large roundworm (A. suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum)infections in swine.For the removal and control of large roundworm (A. suum)infections in swine.
Active Ingredient(s)
  • Pyrantel
Inactive Ingredient(s)
  • MINERAL OIL (T5L8T28FGP)
  • CALCIUM CARBONATE (H0G9379FGK)
  • SOYBEAN (L7HT8F1ZOD)
  • MINERAL OIL (T5L8T28FGP)
  • CALCIUM CARBONATE (H0G9379FGK)
  • SOYBEAN (L7HT8F1ZOD)
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 NADA043290 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.

Banminth 48 Images

Banminth 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



Description



Swine Anthelmintic


Active Drug Ingredient:



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


Indications For Use:



For the removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum)infections in swine.

Aid in the prevention of migration and establishment of large roundworm (A. suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum)infections in swine.

For the removal and control of large roundworm (A. suum)infections in swine.


Warning:



Withdraw 24 hours prior to slaughter.

Withdraw 24 hours prior to slaughter.

CAUTION: Consult your veterinarian before using in severely debilitated animals.

Do not mix in feeds containing bentonite.

NOT FOR HUMAN USE

RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED


Other Warning:Parasite Resistance May Develop To Any Dewormer. All Dewormers Require Accurate Dosing For Best Results. Following The Use Of Any Dewormer, Effectiveness Of Treatment Should Be Monitored. A Decrease Of Effectiveness Over Time May Indicate The Development Of Resistance To The Dewormer Administered. The Parasite Management Plan Should Be Adjusted Accordingly Based On Regular Monitoring. Caution:



For use in the manufacture of complete swine feeds and/or swine protein supplement 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.


Mixing And Use Directions



Complete Swine Feeds Containing 0.0106% (96 g/t) Pyrantel Tartrate

Amount of Banminth 48
per Ton of Complete Feed

Resultant Use Level of PyranteTartrate in Complete Feed

Indications for Use

16.67 lb

0.0881%
(800g/t)

For the removal and control of large roundworm (A. suum) and nodular worm (Oesophagostomum)infections in swine.†


Directions For Use



As a single therapeutic treatment in complete feed; feed at the rate 1 lb of feed per 40 lb of body weight for animals up to 200 lb. For animals 200 lb or over, feed 5 lb of feed per head. Quantity of medicated feed required to treat pigs of various body weight is shown below:

Pig Weight (lb)

20

40

60

80

100

200 and over

Quantity of Feed per Pig

1/2 lb

1 lb

1 1/2 lb

2 lb

2 1/2 lb

5 lb

Fast pigs overnight for optimum results. Pigs will generally consume this quantity of medicated feed within a few hours time after which regular feeding should be resumed. Better worming is achieved when pigs are separated by size into different lots or pens for treatment. Water should be made available to animals during fasting and treatment periods.

Complete Swine Feeds Containing 0.0106% (96 g/t) Pyrantel Tartrate

Amount of Banminth 48
per Ton of Complete Feed

Resultant Use Level of Pyrantel Tartrate in Complete Feed

Indications for Use

Directions for Use

2 lb

0.0106%
(96 g/t)

Aid in the prevention of migration and establishment of large roundworm (A. suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum) infections in swine.

Feed continuously as the sole ration

2 lb

0.0106%
(96 g/t)

For the removal and control of large roundworm (Ascaris suum) infections in swine.†

Feed for 3 days as the sole ration.

Swine Protein Supplements for Further Dilution to Feed Containing 0.0106% (96 g/t) Pyrantel Tartrate

Amount of Banminth 48
per Ton of Protein Supplement*

Indications for Use

Directions

To calculate the amount of Banminth 48 per ton of protein supplement, divide 4000 by the quantity (lb) of protein supplement that will be mixed with grain(s) to produce a ton of complete feed, that is:

4000 ÷ X = lb of Banminth 48 per ton of protein supplement.

where X = quantity (lb) of protein supplement that will be mixed with grain(s) to produce a ton of complete feed.

Example Calculation: Directions for use of the protein supplement require that 500 lb are to be mixed with grain(s) to produce a ton of complete feed.

4000 ÷ 500 = 8 lb of Banminth 48 per

ton of protein supplement.

Aid in the prevention of migration and establishment of large roundworm (A. suum)infections; aid in the prevention of establishment of nodular worm (Oesophagostomum) infections in swine.

Prepare a complete feed by mixing proper quantities of protein supplement with grain(s). If pelleted, grind pellets before or during mixing. The resultant complete feed contains 0.0106% (96 g/t) pyrantel tartrate and is to be fed continuously as the sole ration.

For the removal and control of large roundworm (A. suum) infections in swine.†

Prepare a complete feed by mixing proper quantities of protein supplement with grain(s). If pelleted, grind pellets before or during mixing. The resultant complete feed contains 0.0106% (96 g/t) pyrantel tartrate and is to be fed for 3 days as the sole ration.

Swine Protein Supplements for Further Dilution to Feed Containing 0.0881% (800 g/t) Pyrantel Tartrate

Amount of Banminth 48
per Ton of Protein Supplement*

Indications for Use

Directions for Use

To calculate the amount of Banminth 48 per ton of protein supplement, divide 33,333 by the quantity (lb) of protein supplement that will be mixed with grain(s) to produce a ton of complete feed, that is:

33,333 ÷ X = lb of Banminth 48 per ton of protein supplement.

where X = quantity (lb) of protein supplement that will be mixed with grain(s) to produce a ton of complete feed.

Example Calculation: Directions for use of the protein supplement require that 333 lb are to be mixed with grain(s) to produce a ton of complete feed.

33,333 ÷ 333 = 100 lb of Banminth 48 per ton of protein supplement.

For the removal and control of large roundworm (A. suum)and nodular worm (Oesophagostomum) infections in swine.†

Prepare a complete feed by mixing the proper quantities of protein supplement with grain(s). If pelleted, grind pellets before or during mixing. The resultant complete feed contains 0.0881% (800 g/t) pyrantel tartrate and is to be fed as sole ration for a single therapeutic treatment at the rate of 1 lb of feed per 40 lb of body weight for animals up to 200 lb. For animals 200 lb or over, feed 5 lb of feed per head. Fast pigs overnight for optimum results. Pigs will generally consume this quantity of medicated feed within a few hours time, after which regular feeding should be resumed. Better worming is achieved when pigs are separated by size into different lots or pens for treatment. Water should be made available to animals during fasting and treatment periods.

* To find grams of pyrantel tartrate, multiply lb of Banminth by 48.

† Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.


Other



SEE BACK OF PACKAGE FOR FURTHER USE DIRECTIONS

Banminth® 48 is a Phibro Animal Health Corporation registered trademark for Pyrantel Tartrate

Phibro Animal Health Corporation, Teaneck, NJ 07666.

Net Weight: 50 lb (22.7 kg)

Approved by FDA under NADA #043-290

7909000

101-9015-07

U.S. Patent No. 3,549,624

Made in USA


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