Animal NDC 61133-3401-2 Tetroxy 343
Oxytetracycline Hcl
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 61133-3401-2 |
| Proprietary Name | Tetroxy 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 Hcl 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 | Bimeda, Inc. |
| Product Type | Prescription Animal Drug |
| Usage Information |
|
| Active Ingredient(s) |
|
| 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 | ANADA200247 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. |
Tetroxy 343 Images
Tetroxy 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
Description
Tetroxy® 343
(oxytetracycline hydrochloride)
Soluble Powder
CAUTION: Federal (USA) 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, SHEEP, SWINE AND HONEY BEES.
FOR THE MARKING OF SKELETAL TISSUES IN FINFISH FRY AND FINGERLINGS AS AN AID IN IDENTIFICATION.
This pouch contains 1,715 grams of oxytetracycline hydrochloride.
For oral use only in poultry, cattle, sheep, swine and honey bees.
Fish should be treated by immersion.
FOR USE IN DRINKING WATER ONLY
NOT FOR USE IN LIQUID FEED SUPPLEMENTS
NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN
Restricted Drug (California) - Use Only as Directed
Approved by FDA under ANADA # 200-247
Indications & Usage
INDICATIONS AND DIRECTIONS FOR USE:
POULTRY
For the control of the following poultry diseases caused by organisms susceptible to oxytetracycline: Add the following amount to two gallons of stock solution when proportioner is set to meter at the rate of one ounce per gallon. The enclosed measuring cup holds 68 g (2.4 oz) of product when leveled at the 80 mL mark.
| CHICKENS | DOSAGE | SCOOPS/2 GALLONS STOCK SOLUTION |
| Infectious synovitis caused by Mycoplasma synoviae. | 200-400 mg/gal | 1-2 |
| Chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli. | 400-800 mg/gal | 2-4 |
| Fowl cholera caused by Pasteurella multocida. | 400-800 mg/gal | 2-4 |
| TURKEYS | ||
| Hexamitiasis caused by Hexamita meleagridis. | 200-400 mg/gal | 1-2 |
| Infectious synovitis caused by Mycoplasma synoviae. | 400 mg/gal | 2 |
| Growing Turkeys-Complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis). | 25 mg/lb body weight daily | varies with age & water consumption (1 pound will treat 13,720 pounds of turkeys.) |
Medicate continuously at the first clinical signs of disease and continue for 7 to 14 consecutive days. If improvement is not noted within 24-48 hours, consult a poultry diagnostic laboratory or poultry pathologist to determine diagnosis and advice on dosage. See Residue Warnings.
For the control and treatment of the following diseases caused by organisms susceptible to oxytetracycline:
| 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 hydrochloride per pound of body weight daily. Administer up to 14 days. See Residue Warnings. |
| CALVES, BEEF CATTLE AND NON-LACTATING CATTLE | DOSAGE |
| Bacterial enteritis caused by Escherichia coli. Bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida. | Administer in the drinking water at a level of 10 mg oxytetracycline hydrochloride per pound of body weight daily. Administer up to 14 days. See Residue Warnings. |
| SHEEP | DOSAGE |
Bacterial enteritis caused by Escherichia coli. Bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida. | Administer in the drinking water at a level of 10 mg oxytetracycline hydrochloride per pound of body weight daily. Administer up to 14 days. See Residue Warnings. |
This bucket will treat 171,500 pounds of swine, cattle or sheep at 10 mg/pound. | |
| HONEY BEES | DOSAGE |
| For control of American Foulbrood caused by Paenibacillus larvae susceptible to oxytetracycline. | 200 mg/colony Administer in 3 applications of sugar syrup or 3 dustings at 4 to 5 day intervals. Apply dust on the outer parts or ends of the frames. See Residue Warnings. |
| CONTRAINDICATION: Dusting of uncapped brood cells has been reported to cause death of larval honey bees. Do not dust uncapped brood cells. | |
| FISH | DOSAGE |
| For the marking of skeletal tissues in finfish fry and fingerlings as an aid in identification. | Immerse fry or fingerling finfish in 200 to 700 mg OTC (buffered)/liter of water for 2-6 hours. Solution should be tested on a small number of fish before full-scale use. Once mixed with water, solution should be used immediately. See Residue Warnings. |
Adverse Reactions
ADVERSE REACTIONS: Oxytetracycline hydrochloride 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.
DISPOSAL OF TREATED WATER: Do not discharge marking immersion water containing oxytetracycline into surface waters.
Precautions
PRECAUTION: Prepare fresh solutions every 24 hours.
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: Use as sole source of oxytetracycline. Do not administer to turkeys, cattle or sheep within 5 days of slaughter. Zero-day slaughter withdrawal in swine. Do not administer to chickens or turkeys producing eggs for human consumption. Do not administer this product with milk or milk replacers. Administer 1 hour before or 2 hours after feeding milk or milk replacers. 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 fish. 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.
CONTACT INFORMATION: To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae
Storage And Handling
STORAGE: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.