Label: NEOSOL- neomycin sulfate powder, for solution
- NDC Code(s): 54925-036-35, 54925-036-50
- Packager: Med-Pharmex, Inc
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Drug Label Information
Updated July 13, 2023
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DESCRIPTION
(neomycin sulfate)
Antibacterial
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Approved by FDA under ANADA # 200-235
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.
Net Weight: 50 lb. (22.6 kg) - - Each pound contains: 325 gm neomycin sulfate equivalent to 227.5 gm neomycin.
Net Wt.: 3.5 oz (100g) - - Each packet contains: 71.5 gm neomycin sulfate equivalent to 50 gm neomycin.
Restricted Drug – Use only as Directed (California)
For Oral Use in Animals Only - Add to drinking water – Not for use in liquid supplements
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DOSAGE AND ADMINISTRATION:
Net Weight 50 lb. (22.6kg) Container:
Administer 10 mg neomycin sulfate per pound of body weight per day in divided doses for a maximum of 14 days. 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 treatWeight of calf
10 calves
50 pounds
7calves
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.
Net Wt.: 3.5 oz (100g) Packet:
Administer to cattle (excluding veal calves), swine, sheep and goats at a dose of 10 mg neomycin sulfate per pound of body weight per day in divided doses maximum of 14 days.
Herd 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: Swine - Use the number of packets indicated below in 256 gallons of water or in two gallons of stock solution used in proportioner set to meter one ounce per gallon.
Pig Weighing 25 to 50 pounds ----------------------2 packets
Pig Weighing 50 to 100 pounds --------------------3 packets
Pig Weighing Over 100 pounds ---------------------4 packets
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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.
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WARNINGS AND PRECAUTIONS
WARNINGS:
Not for Use in Humans. Keep out of reach of children.
Residue Warnings: 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-rumination 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.
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STORAGE AND HANDLING
STORAGE:
Store in a dry place. When storing partially used containers, securely close bags to prevent contents from caking.
KEEP CONTAINER TIGHTLY CLOSED - - STORE AT ROOM TEMPERATURE
CONTACT INFORMATION:
To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Med-Pharmex at (800) 587-4306. 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
Manufactured by:
Med-Pharmex, Inc.
Pomona, CA 91767Rev. July 2023
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INGREDIENTS AND APPEARANCE
NEOSOL
neomycin sulfate powder, for solutionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54925-036 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:54925-036-35 100 g in 1 PACKET 2 NDC:54925-036-50 22600 g in 1 DRUM Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200235 03/09/1998 Labeler - Med-Pharmex, Inc (025353699)