Label: BANMINTH 48- pyrantel tartrate powder

  • Category: OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated June 27, 2019

If you are a consumer or patient please visit this version.

  • 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.

  • 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.

  • Store At Or Below 25°C (77°F), EXCURSIONS PERMITTED UP TO 40°C (104°F)

  • 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.

  • WARNING:

    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

  • SPL UNCLASSIFIED SECTION

    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

  • PRINCIPAL DISPLAY PANEL

    Banminth 48-07
  • INGREDIENTS AND APPEARANCE
    BANMINTH 48 
    pyrantel tartrate powder
    Product Information
    Product TypeOTC TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:66104-2391
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRANTEL (UNII: 4QIH0N49E7) (PYRANTEL - UNII:4QIH0N49E7) PYRANTEL48 g  in 0.45 kg
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66104-2391-122.7 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA04329002/06/1973
    Labeler - Phibro Animal Health (006989008)
    Registrant - Phibro Animal Health (006989008)