Aureomycin: Package Insert / Prescribing Information - Drugs.com

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# Aureomycin

Package insert / prescribing information
Generic name: chlortetracycline hydrochloride
Dosage form: FOR ANIMAL USE

Chlortetracycline
Type A Medicated Article

## Active drug ingredient

Chlortetracycline calcium complex equivalent to 100 g chlortetracycline hydrochloride per lb.

## Ingredients

Dried Streptomyces aureofaciens Fermentation Product and Calcium Sulfate.

For use in the manufacture of medicated animal feeds.
For use in dry feed only. Not for use in liquid medicated feeds.

## Use directions

Mix sufficient Aureomycin 100 Granular Medicated Article to supply desired concentration of chlortetracycline per ton with part of the feed ingredients to make a preblend. Add the remainder of the ingredients and mix thoroughly. For specific use levels, see Indications.

## Mixing directions

Level desired grams per ton | Amount of medicated article per ton*
--- | ---

*
  It is recommended that 1 pound of Aureomycin 100 Granular Type A Medicated Article be diluted with 3 pounds of one of the feed ingredients to form a 4 pound working premix. Use 2 pounds of the working premix to make a preblend (see Use directions) for a Type C feed containing 50 g Aureomycin chlortetracycline / ton of feed.

50 | 1/2 lb
100 | 1 lb
200 | 2 lb
400 | 4 lb
500 | 5 lb

Indications | Chlortetracycline mg per lb body wt per day
Cattle |
Calves (up to 250 lb): Increased rate of weight gain and improved feed efficiency. | 0.1
Beef Cattle (over 700 lb): Control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline. | 0.5
Beef and Non-Lactating Dairy Cattle: As an aid in control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline when delivered in a free-choice feed. Free-choice feed must be manufactured under a feed mill license utilizing an FDA approved formulation. | 0.5-2.0
Calves, Beef and Non-Lactating Dairy Cattle: Treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline. Feed for not more than 5 days. The appropriate amount of Aureomycin-containing feed supplement may be mixed in the cattle's daily ration or administered as a top-dress. If the Aureomycin-containing feed supplement is administered as a top-dress, it must be spread uniformly on top of the ration and sufficient space must be provided so that all cattle can eat at the same time. | 10
Swine |

Control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline.
Treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline. (Note: this drug level is equivalent to approximately 400 grams per ton, depending on feed consumption and body weight.)
Feed for not more than 14 days.

10

Turkeys |
Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to chlortetracycline. Feed continuously for 7 to 14 days. | 25
Indications | mg per head per day
Cattle |
Calves (250 to 400 lb): Increased rate of weight gain and improved feed efficiency. | 25-70
Growing Cattle (over 400 lb): Increased rate of weight gain, improved feed efficiency, and reduction of liver condemnation due to liver abscesses. | 70
Beef Cattle: Control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline. | 350
Beef Cattle (under 700 lb): Control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline. | 350
Sheep |
Breeding Sheep: Reduction in the incidence of (vibrionic) abortions caused by Campylobacter fetus infection susceptible to chlortetracycline. | 80
Indications | In complete feed Chlortetracycline g per ton
Swine |
Increased rate of weight gain and improved feed efficiency. | 10-50
Reduction in the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci susceptible to chlortetracycline. | 50-100
Breeding Swine: Control of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to chlortetracycline. Feed continuously for not more than 14 days. | 400
Sheep |
Increased rate of weight gain and improved feed efficiency. | 20-50
Ducks |
Control and treatment of fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline. Feed in complete ration to provide from 8 to 28 mg per pound of body weight per day depending upon age and severity of disease. Feed for not more than 21 days. | 200-400
Chickens |
Increased rate of weight gain and improved feed efficiency. | 10-50
Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline. Feed continuously for 7 to 14 days. | 100-200
Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to chlortetracycline. Feed continuously for 7 to 14 days. | 200-400
Reduction of mortality due to Escherichia coli infections susceptible to chlortetracycline. Feed for 5 days. | 500
Turkeys |
Increased rate of weight gain and improved feed efficiency. | 10-50
Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline. Feed continuously for 7 to 14 days. | 200
Control of hexamitiasis caused by Hexamita meleagridis susceptible to chlortetracycline. Feed continuously for 7 to 14 days. | 400
Turkey Poults not over 4 weeks of age: Reduction of mortality due to paratyphoid caused by Salmonella typhimurium susceptible to chlortetracycline. | 400
Indications | mg per g feed
Psittacine birds |
Warning: Psittacosis, avian chlamydiosis, or ornithosis is a reportable communicable disease, transmissible between wild and domestic birds, other animals and man. Contact appropriate public health and regulatory officials. |
Caution: Aspergilliosis may occur following prolonged treatment. |
Treatment of psittacine birds (parrots, macaws, cockatoos) suspected or known to be infected with psittacosis caused by Chlamydia psittaci sensitive to chlortetracycline. Feed continuously for 45 days. Each bird should consume an amount of medicated feed equal to one-fifth of its body weight daily. During treatment, parrots, macaws, and cockatoos should be kept individually or in pairs in clean cages. | 10

## Warning

A withdrawal period has not been established for this product in pre-ruminating calves.
Do not use in calves to be processed for veal.
Do not feed to ducks or turkeys producing eggs for human consumption.

NADA 48-761, Approved by FDA

Marketed by
Alpharma Inc.
Bridgewater, New Jersey 08807

Trademarks registered
by Alpharma Inc.

700388 0902

## PRINCIPAL DISPLAY PANEL - 50 LB Bag

Aureomycin®
100 Granular

ALPHARMA

GUARANTEED
Aureomycin®
CHLORTETRACYCLINE

Chlortetracycline
Type A Medicated Article

See mixing directions, claims, cautions
and warnings on back

Net wt 50 LB (22.68 kg)

Aureomycin®
100 Granular

## PRINCIPAL DISPLAY PANEL - 2000 LB Supersack

Aureomycin®
100 Granular

Chlortetracycline
Type A Medicated Article

Aureomycin is a registered trademark of Alpharma Inc.

Net wt 2000 LB (907 kg)

AHL-543 0812

Lot No.:

Expiration Date:

AUREOMCYIN chlortetracycline hydrochloride granule

Product Information
Product Type | OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG | Item Code (Source) | NDC:46573-006
Route of Administration | ORAL | DEA Schedule |

Active Ingredient/Active Moiety
Ingredient Name | Basis of Strength | Strength
Chlortetracycline Hydrochloride (Chlortetracycline) | Chlortetracycline Hydrochloride | 100 g in 0.45 kg

Inactive Ingredients
Ingredient Name | Strength
calcium sulfate |

Product Characteristics
Color | GRAY (gray to brown) | Score |
Shape |  | Size |
Flavor |  | Imprint Code |
Contains |

Packaging
# | Item Code | Package Description
1 | NDC:46573-006-00 | 22.68 kg in 1 BAG
2 | NDC:46573-006-18 | 909.1 kg in 1 SUPERSACK

Marketing Information
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date
NADA | NADA048761 | 01/01/2009 |

Labeler - Alpharma Inc. Animal Health (070954094)

Establishment
Name | Address | ID/FEI | Operations
Alpharma Inc. Animal Health |  | 005300025 | MANUFACTURE, ANALYSIS, RELABEL, REPACK

Alpharma Inc. Animal Health

Medical Disclaimer