Wednesday, 5 September 2012

Neomycin Sulfate 325





Dosage Form: FOR ANIMAL USE ONLY
Neomycin Sulfate 325



For the treatment and control of colibacillosis  (Bacterial enteritis) caused by Escherichia coli susceptible to

neomycin sulfate in cattle, swine, sheep and goats.


For the control of mortality associated with Escherichia coli organisms susceptible to neomycin sulfate

in growing turkeys.



Each Packet Contains:

71.5 gm neomycin sulfate, USP

equivalent to 50 gm neomycin


ANADA #200-378, Approved by FDA


Restricted Drug-Use Only As Directed (California)


Take Time Observe Label Directions         Net Wt 3.5 oz (100 grams)




For Use in Animals Only                                  Store at room temperature

Add to drinking water - Not for use in liquid supplements

Dosage and Administration


Dosage and Administration: Administer to turkeys at a dose of 10 mg neomycin sulfate per pound

of body weight per day for 5 days. Administer to cattle, swine, sheep and goats at a dose of 10 mg

neomycin sulfate per pound of body weight per day in divided doses for a maximum of 14 days.


Herd/Flock Treatment: Each packet will treat 7150 pounds body weight.  Therefore, estimate the total

number of pounds of body weight of the animals to be treated and administer one (1) packet (or portion

thereof) for each 7150 pounds. The product should be added to the amount of drinking water estimated

to be consumed in 12-24 hours. Provide medicated water as the sole source of water each day until

consumed, followed by non-medicated water as required. Fresh medicated water should be prepared each day.


Individual Animal Treatment: To provide 10 mg neomycin sulfate per pound of body weight, mix one (1)

level teaspoon in water or milk for each 160 pounds body weight.  Administer daily either as a drench in

divided doses or in the drinking water to be consumed in 12-24 hours.


Drinking Water: Use the number of packets indicated below in 256 gallons of water, or in two gallons

of stock solution used in proportioners set to meter one ounce per gallon.


Swine:


Pigs Weighing 25 to 50 Pounds ............2 Packets

Pigs Weighing 50 to 100 Pounds ..........3 Packets

Pigs Weighing Over 100 Pounds ..........4 Packets




Precautions


Precautions: To administer the stated dosage, the concentration of neomycin required in medicated

water must be adjusted to compensate for variation in age and weight of animal, the nature and severity

of disease signs, and environmental temperature and humidity, each of which affects water consumption.


If symptoms persist after using this preparation for 2 or 3 dyas, consult a veterinarian.  If symptoms such

as fever, depression, or going off feed develop, oral neomycin is not indicated as the sole treatment since

systemic levels of neomycin are not obtained due to low absorption from the gastrointestinal tract.


Important: Treatment should continue 24 to 48 hours beyond remission of disease symptoms, but not to

exceed a total of 14 consecutive days for cattle, swine, sheep, goats, and 5 days for turkeys. Animals not

drinking or eating should be treated individually by drench.


Not for human use. Keep out of reach of children.



RESIDUE WARNINGS




Residue Warnings: Discontinue treatment prior to slaughter by at least the

number of days listed below for the appropriate species:


Turkeys .................................. 0 days

Cattle ...................................... 1 day

Sheep .................................... 2 days

Swine and Goats .................... 3 days


A withdrawal period has not been established for this product in pre-ruminating

calves.  Do not use in calves to be processed for veal.  A milk discard period

has not been established for this product in lactating dairy cattle. Do not use

in female dairy cattle 20 months of age or older.


Use of more than one product containing neomycin or failure to follow

withdrawal times may result in illegal drug residues.


N - 0325 - 01                                                                                 Rev. 07-09


Lot No.               Exp. Date









NEOMYCIN SULFATE  325
antibacterial  powder, for solution










Product Information
Product TypeOTC ANIMAL DRUGNDC Product Code (Source)58005-325
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (NEOMYCIN)NEOMYCIN SULFATE50 g  in 100 g





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
158005-325-01100 g In 1 PACKETNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20037807/31/2007


Labeler - Sparhawk Laboratories, Inc. (958829558)
Revised: 02/2010Sparhawk Laboratories, Inc.



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