Label: BIO-COX TYPE A MEDICATED ARTICLE- salinomycin sodium powder
- NDC Code(s): 23243-6807-5
- Packager: Huvepharma, Inc.
- 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
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- SPL UNCLASSIFIED SECTION
- DOSAGE & ADMINISTRATION
-
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 Activity Amount of Bio-Cox
Type A Medicated Article (60 g/lb)
Per Ton of Feed(grams per ton) lb grams 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
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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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BIO-COX TYPE A MEDICATED ARTICLE
salinomycin sodium powderProduct Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:23243-6807 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALINOMYCIN SODIUM (UNII: 92UOD3BMEK) (SALINOMYCIN - UNII:62UXS86T64) SALINOMYCIN SODIUM 60 g in 0.45 kg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:23243-6807-5 22.68 kg in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA128686 01/01/2020 Labeler - Huvepharma, Inc. (619153559) Registrant - Huvepharma EOOD (552671651) Establishment Name Address ID/FEI Business Operations Huvepharma, Inc - Van Buren 080346352 medicated animal feed manufacture, analysis, pack, label, manufacture