PENNOX 343- oxytetracycline hydrochloride powder

Pennox 343 by

Drug Labeling and Warnings

Pennox 343 by is a Animal medication manufactured, distributed, or labeled by Pharmgate Animal Health, Pharmgate Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRECAUTIONS

PRECAUTIONS: Prepare fresh solution every 24 hours. Use as sole source of oxytetracycline. Not to be used for more than 14 consecutive days in chickens and turkeys or 5 consecutive days in cattle, swine or sheep. FOR USE IN DRINKING WATER ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS.

SPL UNCLASSIFIED SECTION

SPECIAL NOTE: The concentration of drug required in medicated water must be adequate to compensate for variation in the age of the animal, feed consumption rate and the environmental temperature and humidity, each of which affects water consumption.

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.

STORAGE AND HANDLING

RECOMMENDED STORAGE: STORE BELOW 104°F (40°C).
FOR ANIMAL USE ONLY. KEEP OUT OF REACH OF CHILDREN.

Not for human use. Use Only As Directed.

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 daily	Varies 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 Pomona	Administer 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 multocida	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.
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.

SPL UNCLASSIFIED SECTION

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PRINCIPAL DISPLAY PANEL - 677.6 g Pouch Label

CUT HERE

Pennox 343®
(oxytetracycline HCl)
Soluble Powder

CAUTION: 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 gallon

1,280 gallons (4,845 L) containing 400 mg oxytetracycline
HCl per gallon

640 gallons (2,420 L) containing 800 mg oxytetracycline
HCl per gallon

For oral use only in poultry, cattle, sheep, swine and
honey bees. Fish should be treated by immersion

Net Contents: 23.9 oz (677.6 g)
ANADA 200-026
APPROVED BY FDA
Not For Human Use.
#F343-2
4/18

Pharmgate
ANIMAL HEALTH

Marketed by:
Pharmgate Animal Health, LLC
14040 Industrial Road
Omaha, Nebraska 68144

INGREDIENTS AND APPEARANCE

PENNOX 343 
oxytetracycline hydrochloride powder

Product 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 LLC (079628671)