Label: BIO-COX TYPE A MEDICATED ARTICLE- salinomycin sodium powder

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

Drug Label Information

Updated September 13, 2023

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

  • SPL UNCLASSIFIED SECTION

    Bio-Cox®

    Type A Medicated Article

    Brand of Salinomycin Sodium
    Type A Medicated Article

    Net wt 50 LB (22.68 kg)

    HUVEPHARMA®

  • DOSAGE & ADMINISTRATION

    Bio-Cox®
    Type A Medicated Article

    Brand of Salinomycin Sodium
    Type A Medicated Article

    For use in broiler chickens, replacement chickens, and quail only

    Active drug ingredient

    Salinomycin equivalent to 60 grams salinomycin sodium activity per pound

    For use in manufacturing medicated feeds only

  • VETERINARY INDICATIONS

    Broiler chickens and replacement chickens

    Use Bio-Cox Type A Medicated Article to provide salinomycin sodium
    concentrations ranging from 40-60 g/ton (0.0044% to 0.0066%) for the
    prevention of coccidiosis in broiler chickens and replacement chickens
    caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti
    and E. mivati. The dosage should be adjusted to meet the severity of the
    coccidial challenge, which varies with environmental and managment
    conditions.

    Quail

    Use Bio-Cox Type A Medicated Article to provide salinomycin sodium
    concentrations of 50 g/ton (0.0055%) for the prevention of coccidiosis in
    quail caused by Eimeria dispersa and E. lettyae.

  • INDICATIONS & USAGE

    Mixing directions

    Thoroughly mix Bio-Cox Type A Medicated Article with non-medicated feed
    to provide the level of salinomycin sodium per ton as indicated in the table below.

    Salinomycin Sodium ActivityAmount of Bio-Cox 
    Type A Medicated Article (60 g/lb)
    Per Ton of Feed
    (grams per ton) lbgrams 

    40

    45

    50

    55

    60

    0.67

    0.75

    0.83

    0.92

    1.00 

    304

    341

    377

    418

    454

    Feeding directions

    Feed continuously as the sole ration

    Important

    Must be thoroughly mixed in feeds before use. Not approved for use with
    pellet binders.

  • PRECAUTIONS

    Caution

    May be fatal if accidentally fed to adult turkeys or to horses.

  • WARNINGS

    Warning

    Do not feed to birds producing eggs for human consumption.
    When mixing and handling Bio-Cox Type A Medicated Article
    premix, use protective clothing, impervious gloves, eye protection,
    and an approved dust respirator. Operators should wash thoroughly
    with soap and water after handling. If accidental eye contact
    occurs, immediately rinse thoroughly with water.

  • STORAGE AND HANDLING

    Store below 25°C (77°F), excursions permitted to 37°C (99°F)
    Restricted drug (California) - Use only as directed. Not for human use.
    Approved by FDA under NADA # 128-686

  • SPL UNCLASSIFIED SECTION

    HUVEPHARMA®

    Distributed by:
    Huvepharma, Inc.
    Peachtree City, GA 30269

    HUVEPHARMA and Bio-Cox are registered trademarks of Huvepharma EOOD.

    Made in USA

    Net wt 50 LB (22.68 kg)

    Take Time

  • PRINCIPAL DISPLAY PANEL

    Bag Label Front

    Back Label Back

  • INGREDIENTS AND APPEARANCE
    BIO-COX TYPE A MEDICATED ARTICLE 
    salinomycin sodium powder
    Product Information
    Product TypeOTC TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:23243-6807
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALINOMYCIN SODIUM (UNII: 92UOD3BMEK) (SALINOMYCIN - UNII:62UXS86T64) SALINOMYCIN SODIUM60 g  in 0.45 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23243-6807-522.68 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA12868601/01/2020
    Labeler - Huvepharma, Inc. (619153559)
    Registrant - Huvepharma EOOD (552671651)
    Establishment
    NameAddressID/FEIBusiness Operations
    Huvepharma, Inc - Van Buren080346352medicated animal feed manufacture, analysis, pack, label, manufacture