BIO-COX 60- salinomycin sodium powder

Bio-Cox Type A Medicated Article by

Drug Labeling and Warnings

Bio-Cox Type A Medicated Article by is a Animal medication manufactured, distributed, or labeled by Huvepharma, Inc., Huvepharma EOOD, Huvepharma, Inc - Van Buren. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Front Panel

Bio-Cox®

Granular 60

Brand of Salinomycin Sodium

Type A Medicated Article

Net wt 50 LB (22.68 kg)

HUVEPHARMA®

Bag Back Panel - Mixing Directions and Permitted Claims

Bio-Cox®
Granular 60

Brand of Salinomycin Sodium
Type A Medicated Article

For use in broiler, roaster, replacement
(breeder and layer) chickens, and quail only

Active drug ingredient

Salinomycin equivalent to 60 grams salinomycin sodium activity per pound

For use in manufacturing medicated feeds only

Mixingdirections

Thoroughly mix Bio-Cox 60 Granular 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 60 Granular

                                          Type A Medicated Article (60 g/lb) Per Ton of Feed
(grams per ton)                      lb             grams
         40                               0.67          304
         45                               0.75          341
         50                               0.83          377
         55                               0.92          418
         60                               1.00          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.

Restricted drug (California) - Use only as directed. Not for human use.
NADA #128-686, Approved by FDA

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)

P08-400310

Rev. 06-2016

Back Panel - Indications

Broiler, roaster and replacement (breeder and layer) chickens

Use Bio-Cox 60 Granular to provide salinomycin sodium concentrations ranging
from 40-60 g/ton (0.0044% to 0.0066%) for the prevention of coccidiosis in
broiler, roaster 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 management conditions.

Quail

Use Bio-Cox 60 Granular 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.

Caution

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

Warning

Do not feed to laying hens producing eggs for human consumption.
When mixing and handling Bio-Cox 60 Granular 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.

Back Panel - Storage 

Store below 25°C (77°F), excursions permitted to 37°C (99°F)

Bag Label Image

INGREDIENTS AND APPEARANCE

BIO-COX  60
salinomycin sodium powder

Product 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 (552691651)

Establishment
Name	Address	ID/FEI	Business Operations
Huvepharma, Inc - Van Buren		080346352	medicated animal feed manufacture, analysis, pack, label