Label: NEOMYCIN - neomycin sulfate liquid
- NDC Code(s): 30798-340-31, 30798-340-35
- Packager: Durvet, Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- FOR ANIMAL USE ONLY
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.
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For Oral Use in Animals Only
- Dosage and Administration
Administer to cattle (excluding veal calves), swine, sheep and goats at a dose of 10 mg neomycin sulfate per pound of body weight in divided doses for a maximum of 14 days.Dosage Schedule for treatment of colibacillosis
Pounds of Amount of Neomycin Solution
Body Weight Per Day in Divided Doses
25 lb 1.2 mL (1/4 tsp*)
50 lb 2.5 mL (1/2 tsp*)
100 lb 5 mL (1 tsp*)
300 lb 15 mL (1 tbsp*)
591.5 lb 29.5 mL (1 fl oz)
* Teaspoon (tsp) / Tablespoon (tbsp) is equal to U.S. Standard Measure
Neomycin Solution may be given undiluted or diluted with water.
Herd Treatment: Each bottle will treat 9,600 pounds of body weight. Therefore, estimate the total number of pounds body weight of the animals to be treated and administer on (1) fluid ounce of each 600 pounds. The product should be added to the amount of drinking water 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) teaspoon in water or milk for each 100 pounds of body weight. Administer daily either as a drench in divided doses or in the drinking water to be consumed in 12-24 hours.
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.
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Contains per mL: neomycin sulfate 200 mg equivalent to 140 mg neomycin
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.Close
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.Close
- Residue 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
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.Close
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.
- STORAGE AND HANDLING
Store at controlled room temperature 20o to 25oC (68 to 77oF) (see USP).
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- NEOMYCIN LIQUID
FOR ORAL USE ONLY
ANADA 200-379, Approved by FDA
- INGREDIENTS AND APPEARANCE
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:30798-340 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEOMYCIN SULFATE (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin 140 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30798-340-31 473 mL in 1 BOTTLE 2 NDC:30798-340-35 3823 mL in 1 JUG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200379 07/31/2007 Labeler - Durvet, Inc. (056387798)