AUREOMYCIN- chlortetracycline hydrochloride granule

Aureomycin by

Drug Labeling and Warnings

Aureomycin by is a Animal medication manufactured, distributed, or labeled by Phibro Animal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Aureomycin®

50 Granular A

Chlortetracycline
Type A Medicated Article

Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

Net Wt 50 LB (22.68 kg)

Active drug ingredient

Chlortetracycline calcium complex equivalent to 50 g chlortetracycline hydrochloride per lb.

Ingredients

Aureomycin Granular Type A Medicated Article (Dried Streptomyces aureofaciens Fermentation Product and Calcium Sulfate) and Calcium Carbonate.

PURPOSE

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 50 Granular A 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 for use.

Mixing directions

Level desired grams per ton	Amount of medicated article per ton †
10	1/5 lb
50	1 lb
100	2 lb
200	4 lb
400	8 lb
500	10 lb

† It is recommended that 1 pound of Aureomycin 50 Granular A Type A Medicated Article be diluted with 4 pounds of one of the feed ingredients to form a 5 pound working premix. Use 1 pound of the working premix to make a preblend (see Use directions) for a Type C feed containing 10 g Aureomycin chlortetracycline / ton of feed.

Indications for use

• Indications for use: Chlortetracycline; mg per lb body; wt per day
• 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 the 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
• 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
• Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to chlortetracycline. Feed continuously for 7 to 14 days.: 25
• Indications for use: mg per head; per day
• Growing Cattle (over 400 lb): For the reduction of incidence of liver abscesses.: 70
• Beef Cattle and Dairy Replacement Heifers: 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
• Breeding Sheep: Reduction in the incidence of (vibrionic) abortions caused by Campylobacter fetus infection susceptible to chlortetracycline.: 80
• Indications for use: In complete feed Chlortetracycline g per ton
• 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
• 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
• 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
• 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 for use: mg per g feed
• 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

Withdrawal Periods and Residue Warnings

No withdrawal period is required when used according to labeling. This drug is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. 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.

NO TITLE

Store below 25°C (77°F), excursions permitted to 37°C (99°F)
Restricted Drug (California) - Use only as directed. Not for use in humans. Keep out of reach of children.

Approved by FDA under NADA # 048-761

 

Questions/Comments? For technical assistance or to obtain a Safety Data Sheet(s), contact Phibro Animal Health Corporation at 1-888-403-0074 or ww.pahc.com. To report side effects, contact Phibro Animal
Health Corporation at 1-888-475-7355. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

Phibro, Phibro logo, Aureomycin and the A logo are trademarks owned by or licensed to Phibro Animal Health Corporation or its affiliates.

Distributed by:

Phibro Animal Health Corporation

Teaneck, NJ 07666

Net Wt 50 LB (22.68 kg)

176-9052-02

Take Time Statement

PRINCIPAL DISPLAY PANEL

Aureomycin 50 A Granular Label

INGREDIENTS AND APPEARANCE

AUREOMYCIN 
chlortetracycline hydrochloride granule

Product Information
Product Type	VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 66104-1002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORTETRACYCLINE HYDROCHLORIDE (UNII: O1GX33ON8R) (CHLORTETRACYCLINE - UNII:WCK1KIQ23Q)	CHLORTETRACYCLINE HYDROCHLORIDE	50 g  in 0.45 kg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
CALCIUM SULFATE (UNII: WAT0DDB505)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66104-1002-0	22.68 kg in 1 BAG

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

Labeler - Phibro Animal Health (006989008)