Sacox 60

Dosage Form: FOR ANIMAL USE ONLY
Sacox 60

FRONT PANEL

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

Other Ingredients

Calcium Carbonate, Mineral Oil, Calcium Silicate and Silicon Dioxide

Indications for Use

Broiler, roaster and replacement (breeder and layer) chickens

Use Sacox 60 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 Sacox 60 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.

Mixing and Feeding Directions

Mixing and Feeding Directions

Mixing Directions

Thoroughly mix Sacox® 60 with non-medicated feed to provide the

level of salinomycin sodium per ton as indicated in the table below.


Salinomycin Sodium                     Amount of Sacox® 60 Type A Medicated

Activity                                        Article (60 g/lb) Per Ton of Feed

(grams per ton)                             Lbs                     Grams

40                                               0.67                     304

45                                               0.75                     341

50                                               0.83                     377

55                                               0.92                     418

60                                               1.00                     454

Feed continuously as the sole ration

Important

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

Caution

CautionCaution

May be fatal if fed to adult turkeys or to horses

Warning

Warning

Do not feed to laying hens producing eggs for human consumption. When mixing and handling Sacox 60 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

Storage and Handling

Store in a cool, dry place

ANADA #200-075, Approved by FDA

Distributed by:

Huvepharma, Inc.

Peachtree City, GA 30269

Net Wt. 50 lb. (22.68 kg)

Bag Label Image

Bag Label Image

Sacox 60  salinomycin  powder

Product Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG NDC Product Code (Source) 23243-2050 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALINOMYCIN (SALINOMYCIN) SALINOMYCIN 60 g  in 0.45 kg

Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE   CALCIUM SILICATE   MINERAL OIL   SILICON DIOXIDE

Product Characteristics Color white ((Off White to Tan)) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 23243-2050-5 22.68 kg In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200075	06/29/2009

Labeler - Huvepharama, Inc. (619153559)

Registrant - Huvepharma AD (552691651)

Establishment
Name	Address	ID/FEI	Operations
Huvepharma, Inc.		619153559	manufacture, analysis

Revised: 01/2010Huvepharama, Inc.