Animal NDC 51429-343-02 Pennox 343
Oxytetracycline Hydrochloride
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 51429-343-02 |
| Proprietary Name | Pennox 343 What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
| Non-Proprietary Name | Oxytetracycline Hydrochloride What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
| Labeler Name | Pharmgate Animal Health |
| Product Type | Prescription Animal Drug |
| Usage Information |
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| Active Ingredient(s) |
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| Marketing Category | ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| FDA Application Number | ANADA200026 What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
Pennox 343 Images
Pennox 343 Animal Product Labeling Information
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Table of Contents
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.
Other
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.
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
Take TimeObserve Directions
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.
For the control and treatment of the following diseases caused by organisms susceptible to oxytetracycline.
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. |
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)
Approved by FDA under ANADA # 200-026
Not For Human Use.
#F343-2
6/22
Pharmgate
ANIMAL HEALTH
Marketed by:
Pharmgate Animal Health, LLC
14040 Industrial Road
Omaha, Nebraska 68144
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.
