PENNOX 100 HI-FLO- oxytetracycline powder

Pennox 100 Hi-Flo by

Drug Labeling and Warnings

Pennox 100 Hi-Flo by is a Animal medication manufactured, distributed, or labeled by Pharmgate Animal Health, Pharmgate LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Oxytetracyline
Type A Medicated Article

DESCRIPTION

Active Drug Ingredients: Oxytetracycline (from oxytetracycline dihydrate base) equivalent to 100 grams Oxytetracycline Hydrochloride/lb.

Ingredients: Oxytetracycline, Calcium Carbonate, Roughage Products and Mineral Oil.

FOOD SAFETY WARNING

For Use in the Manufacture of Medicated Feeds. Do Not Feed Undiluted.

CAUTION: For use in Dry Feeds ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS

Directions For Use

INDICATIONS FOR USE	Use Level of Oxytetracycline	lbs. of Pennox 100 Hi-Flo per ton
NADA 138-938 Approved by FDA; Pennox 100 Hi-Flo® is a registered trademark of Pharmgate LLC
Chickens
For Chickens: Control of infectious synovitis caused by Mycoplasma synoviae, control of fowl cholera caused by Pasteurella multocida sensitive to oxytetracycline. (Feed continuously for 7 - 14 days)	100-200 g/ton	1.0 – 2.0
RESIDUE WARNING: DO NOT FEED TO CHICKENS PRODUCING EGGS FOR HUMAN CONSUMPTION. ZERO-DAY WITHDRAWAL PERIOD. DO NOT USE IN LOW CALCIUM FEED CONTAINING LESS THAN 0.55% DIETARY CALCIUM. USE IN SUCH FEEDS MAY RESULT IN VIOLATIVE RESIDUES.
For Chickens: Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to oxytetracycline. (Feed continuously for 7 - 14 days).	400 g/ton	4.0
RESIDUE WARNING: DO NOT FEED TO CHICKENS PRODUCING EGGS FOR HUMAN CONSUMPTION. ZERO-DAY WITHDRAWAL PERIOD. DO NOT USE IN LOW CALCIUM FEED CONTAINING LESS THAN 0.55% DIETARY CALCIUM. USE IN SUCH FEEDS MAY RESULT IN VIOLATIVE RESIDUES.
For Broiler Chickens: Reduction of mortality due to air sacculitis (air sac infection) caused by Escherichia coli susceptible to oxytetracycline (Feed continuously for 5 days).	500 g/ton	5.0
RESIDUE WARNING: DO NOT FEED TO CHICKENS PRODUCING EGGS FOR HUMAN CONSUMPTION. 24 HOURS WITHDRAWAL PERIOD. DO NOT USE IN LOW CALCIUM FEED CONTAINING LESS THAN 0.55% DIETARY CALCIUM. USE IN SUCH FEEDS MAY RESULT IN VIOLATIVE RESIDUES.
Turkeys
For Turkeys: Control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline. (Feed continuously for 7 - 14 days).	100 g/ton	1.0
RESIDUE WARNING: DO NOT FEED TO TURKEYS PRODUCING EGGS FOR HUMAN CONSUMPTION.
For Turkeys: Control of infectious synovitis caused by Mycoplasma synoviae susceptible to oxytetracycline (Feed continuously for 7 - 14 days)	200g/ton	2.0
RESIDUE WARNING: DO NOT FEED TO TURKEYS PRODUCING EGGS FOR HUMAN CONSUMPTION.
For Turkeys: Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to oxytetracycline. (Feed continuously for 7 - 14 days)	25 mg/lb. body weight/day
RESIDUE WARNING: DO NOT FEED TO TURKEYS PRODUCING EGGS FOR HUMAN CONSUMPTION. ZERO-DAY WITHDRAWAL PERIOD.
Swine
For Swine: Treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline. (Feed continuously for 7-14 days.)	Feed approximately 400 g/t, varying with body weight and feed consumption to provide 10 mg/lb. body weight/ day
For Breeding Swine: Control and treatment of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline. (Feed continuously for 14 days)	Feed approximately 400 g/t, varying with body weight and feed consumption to provide 10 mg/lb. body weight/ day
RESIDUE WARNING: ZERO-DAY WITHDRAWAL PERIOD.
Calves, Beef Cattle, and Nonlactating Dairy Cattle
RESIDUE WARNING: THIS DRUG PRODUCT IS NOT APPROVED FOR USE IN FEMALE DAIRY CATTLE 20 MONTHS OF AGE OR OLDER, INCLUDING DRY DAIRY COWS. USE IN THESE CATTLE MAY CAUSE DRUG RESIDUES IN MILK AND/OR IN CALVES BORN TO THESE COWS.
For Growing cattle (over 400 lbs.): For the reduction of the incidence of liver abscesses. (Use continuously)	75 mg/head/day
For Cattle: For the prevention and treatment of the early stages of the shipping fever complex. (Feed 3-5 days before and after arrival in feedlots.)	0.5-2.0g/head/day
For Calves, Beef Cattle, and Nonlactating Dairy Cattle: Treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline. (Feed continuously for 7-14 days)	10 mg/lb. body weight/day
RESIDUE WARNING: 5-DAY WITHDRAWAL PERIOD AT 10MG/LB. DOSAGE.
Sheep
For Sheep: Treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline. (Feed continuously for 7-14 days)	10 mg/lb. body weight/day
RESIDUE WARNING: 5-DAY WITHDRAWAL PERIOD AT 10MG/LB. DOSAGE.
Honey Bees
For Honey Bees: For control of American Foulbrood caused by Paenibacillus larvae and European Foulbrood caused by Streptococcus pluton susceptible to oxytetracycline.	200mg/colony
RESIDUE WARNING: REMOVE AT LEAST 6 WEEKS PRIOR TO MAIN HONEY FLOW. (USE DIRECTIONS AVAILABLE UPON REQUEST.)

SPL UNCLASSIFIED SECTION

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

Take TimeObserve Directions

PRINCIPAL DISPLAY PANEL - 22.68 Kg Bag Label

Pennox 100 Hi-Flo®

Oxytetracycline
Type A Medicated Article

CAUTION: Federal law restricts medicated feed containing this
veterinary feed directive (VFD) drug to use by or on the order of a
licensed veterinarian.

See mixing directions, claims, cautions and warnings on back.
Restricted Drug (California) - Use Only as Directed.
Not For Human Use.

Net wt. 50 LB (22.68 Kg)

PharmGate
Animal Health

INGREDIENTS AND APPEARANCE

PENNOX 100 HI-FLO 
oxytetracycline powder

Product Information
Product Type	VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 51429-103
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Oxytetracycline (UNII: X20I9EN955) (Oxytetracycline Anhydrous - UNII:SLF0D9077S)	Oxytetracycline	220 g  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
Calcium Carbonate (UNII: H0G9379FGK)
Mineral Oil (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51429-103-02	22.68 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA138938	12/23/2008

Labeler - Pharmgate Animal Health (833270817)

Registrant - Pharmgate Inc. (079628671)