Label: NEOMYCIN - neomycin sulfate liquid
- NDC Code(s): 58005-105-05, 58005-105-07
- Packager: Sparhawk Laboratories, 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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- INDICATIONS & USAGE
FOR ANIMAL USE ONLY
KEEP OUT OF REACH OF CHILDREN
Indicated for the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate in cattle, swine, sheep and goats.
Contains per mL: neomycin sulfate 200 mg equivalent to 240 mg neomycin.
Restricted Drug-Use As Directed (California)
For Oral Use in Animals Only
ANADA#: 200-379 Approved by F.D.A.
Dosage and Administration
Administer to cattle, 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 Liquid
Body Weight Per Day in Divided Doses
25 lbs 1/4 teaspoonful
50 lbs 1/2 teaspoonful
100 lbs 1 teaspoonful
300 lbs 1 tablespoonful
600 lbs 1 fluid ounce
Teaspoon = U.S. Standard Measure
Neomycin Liquid may be given undiluted with water.
Herd Treatment: Each bottle will treat 9,600 pounds body weight. Therefore, estimate the total number pounds body weight of the animals to be treated and ad minister one (1) fluid ounce for 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 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.Close
- ASK DOCTOR
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.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).
TAKE TIME OBSERVE LABEL DIRECTIONSClose
- INGREDIENTS AND APPEARANCE
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:58005-105 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:58005-105-05 473 mL in 1 BOTTLE 2 NDC:58005-105-07 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 - Sparhawk Laboratories, Inc. (147979082)