NEOSOL- neomycin sulfate powder, for solution

NEOSOL by

Drug Labeling and Warnings

NEOSOL by is a Animal medication manufactured, distributed, or labeled by Dechra Veterinary Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Neomycin Sulfate

Antibacterial

Approved by FDA under ANADA # 200-235

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Indicated for the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli  susceptible to neomycin sulfate in cattle (excluding veal calves), swine, sheep and goats.

Each pound contains: 325 gm neomycin sulfate equivalent to 227.5 gm neomycin.

Net Weight: 50 lb. (22.6 kg)

Restricted Drug – Use only as Directed (California)

For Oral Use in Animals Only

Add to drinking water – Not for use in liquid supplements.

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION:

Administer 10 mg neomycin sulfate per pound of body weight, per day, in divided doses for a maximum of 14 days.

Net Weight 50 lb. (22.6kg) Container:

Using measuring spoons, the recommended dosage can be determined as follows:

Daily Schedule for Drinking Water

SWINE
One tablespoonful* of Neosol Solubel Powder added to water consumed in one day will treat	Weight of each pig
50 pigs	10 pounds
20 pigs	25 pounds
10 pigs	50 pounds

CATTLE (Not to be used in veal calves)
One tablespoonful* of Neosol; Solubel Powder added to water or; milk consumed in one day will treat	Weight of calf
10 calves	50 pounds
7 calves	75 pounds
4 calves	125 pounds

* Level Tablespoonful = US Standard Measure

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. For a stock solution, add six level tablespoonfuls to one gallon of water. Each pint of this stock solution will medicate 5 gallons of drinking water. For use in Automatic Proportioners delivering 2 ounces of stock solution per gallon of drinking water, dissolve 9 level tablespoonfuls in a gallon of water to make the stock solution.

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.

PRECAUTIONS

CAUTION: 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 days, 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.  Animals not drinking or eating should be treated individually by drench.

WARNINGS AND PRECAUTIONS

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

Discontinue treatment prior to slaughter by at least the number of days listed below for appropriate species:

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

Swine and goats...........3 days

Sheep..........................2 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 residue.

CONTACT INFORMATION:  To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Dechra at (866) 933-2472.  For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae

STORAGE AND HANDLING

STORAGE:  Store at room temperature.  Keep Container Tightly Closed.  

Important: Store in a dry place. When storing partially used containers, securely close bags to prevent contents from caking.

Manufactured for:
Dechra Veterinary Products, LLC
Overland Park, KS 66211

Rev. 05/2023

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NEOSOL 
neomycin sulfate powder, for solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 17033-417
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	50 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17033-417-50	22600 g in 1 DRUM

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200235	05/17/2023

Labeler - Dechra Veterinary Products (362142734)