Label: PENNOX 343- oxytetracycline hydrochloride powder
- NDC Code(s): 51429-343-02
- Packager: Pharmgate Animal Health
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Drug Label Information
Updated October 18, 2022
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RESIDUE WARNING
RESIDUE WARNINGS: Do not administer to cattle or sheep within 5 days of slaughter. Zero day withdrawal in chickens, turkeys and swine. Do not administer to chickens or turkeys producing eggs for human consumption. 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. An additional withdrawal time beyond the grow-out period is not needed for finfish. For honey bees, the drug should be fed early in the spring or fall and consumed by the bees before main honey flow begins to avoid contamination of production honey. Remove at least 6 weeks prior to main honey flow.
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VETERINARY INDICATIONS
Indications and Directions For Use
For the control of the following poultry diseases caused by organisms susceptible to oxytetracycline.
Add the following amount to ten gallons of stock solution when proportioner is set to meter at the rate of one ounce per gallon.
Chickens Dosage Packs/10 Gallons Stock Solution Infectious synovitis caused by Mycoplasma synoviae 200-400 mg/gal ½ - 1 Chronic respiratory disease (CRD) and air-sac infection caused by Mycoplasma gallisepticum and Escherichia coli 400-800 mg/gal 1-2 Fowl cholera caused by Pasteurella multocida 400-800 mg/gal 1-2 Turkeys Hexamitiasis caused by Hexamita meleagridis 200-400 mg/gal ½ - 1 Infectious synovitis caused by Mycoplasma synoviae 400 mg/gal 1 Growing Turkeys – Complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) 25 mg/lb body
weight dailyVaries with age & water consumption (1 pack will treat 20,480 lbs of turkeys) Medicate continuously at the first clinical signs of disease and continue for 7-14 consecutive days. If improvement is not noted within 24-48 hours, consult a veterinarian or a diagnostic laboratory to determine diagnosis and advice on dosage. See Residue Warnings. Finfish For the marking of skeletal tissues in finfish fry and fingerlings.
Immerse in 200-700mg oxytetracycline HCl (buffered)/L of water for 2-6 hours. Solution should be tested on a small number of fish before full-scale use. See Residue Warnings.
DISPOSAL OF TREATED WATERS: Do not discharge marking immersion water containing oxytetracycline into surface waters.
ADVERSE REACTIONS: Oxytetracycline HCl will acidify the water. The pH should be maintained at an acceptable level for fish by the addition of a buffer. Monitor water quality and temperature.Swine Dosage Bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis
Bacterial pneumonia caused by Pasteurella multocida
For Breeding Swine: Leptospirosis (reducing the incidence of abortions and shedding of leptospira) caused by Leptospira PomonaAdminister in the drinking water at a level of 10 mg oxytetracycline HCl per lb of body weight daily. Administer up to 5 days. See Residue Warnings. Calves, Beef Cattle and Non-Lactating Dairy Cattle Bacterial enteritis caused by Escherichia coli
Bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida
Do not mix this product with milk or milk replacers. Administer one hour before or two hours after feeding milk or milk replacers.Administer in the drinking water at a level of 10mg oxytetracycline HCl per lb of body weight daily. Administer up to 5 days. See Residue Warnings. Sheep Bacterial enteritis caused by Escherichia coli
Bacterial pneumonia (shipping fever complex) caused by Pasteurella multocidaAdminister in the drinking water at a level of 10mg oxytetracycline HCl per lb of body weight daily. Administer up to 5 days. See Residue Warnings. This packet will treat 51,200 lbs of swine, cattle or sheep at 10 mg/lb. Honey Bees For control of American Foulbrood caused by Paenibacillus larvae susceptible to oxytetracycline.
CONTRAINDICATION: Dusting of uncapped brood cells has been reported to cause death of larval honey bees. Do not dust uncapped brood cells.200 mg/colony
Administer in 3 applications of 1:1 sugar syrup (equal parts of sugar and water weight to weight) or 3 dustings at 4-5 day intervals. Apply dust on the outer parts or ends of the frames. See Residue Warnings. -
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For technical assistance or to obtain a copy of the Safety Data Sheet, contact Pharmgate Animal Health LLC at 1-800-380-6099 or www.pharmgate.com. To report suspected adverse drug events, contact Pharmgate Animal Health LLC at 1-833-531-0114. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae
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PRINCIPAL DISPLAY PANEL - 677.6 g Pouch Label
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Pennox 343®
(oxytetracycline HCl)
Soluble PowderCAUTION: Federal law restricts this drug to
use by or on the order of a licensed veterinarian.A Broad-Spectrum Antibiotic
For control and treatment of specific diseases in
poultry, cattle, swine, sheep and honey bees.
For the marking of skeletal tissues in finfish fry
and fingerlings.Each packet contains 512 grams of
oxytetracycline HCl and will make:2,560 gallons (9,690 L) containing 200 mg oxytetracycline
HCl per gallon1,280 gallons (4,845 L) containing 400 mg oxytetracycline
HCl per gallon640 gallons (2,420 L) containing 800 mg oxytetracycline
HCl per gallonFor oral use only in poultry, cattle, sheep, swine and
honey bees. Fish should be treated by immersionNet Contents: 23.9 oz (677.6 g)
Approved by FDA under ANADA # 200-026
Not For Human Use.
#F343-2
6/22Pharmgate
ANIMAL HEALTHMarketed by:
Pharmgate Animal Health, LLC
14040 Industrial Road
Omaha, Nebraska 68144
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INGREDIENTS AND APPEARANCE
PENNOX 343
oxytetracycline hydrochloride powderProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:51429-343 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Oxytetracycline Hydrochloride (UNII: 4U7K4N52ZM) (Oxytetracycline Anhydrous - UNII:SLF0D9077S) Oxytetracycline Hydrochloride 0.756 g in 1000 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51429-343-02 677.6 g in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200026 09/01/1997 Labeler - Pharmgate Animal Health (833270817) Registrant - Pharmgate Inc. (079628671)
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