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Animal NDC 54771-1203-2 Terramycin Scours

Oxytetracycline Hydrochloride

Animal Product Information

Field Name Field Value
Animal NDC Code 54771-1203-2
Proprietary Name Terramycin Scours 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 Zoetis Inc.
Product Type Prescription Animal Drug
Usage Information
    Terramycin Scours Tablets are recommended for oral administration for the control and treatment of the following diseases in beef and dairy calves caused by organisms sensitive to oxytetracycline: bacterial enteritis caused by Salmonella typhimurium and Escherichia coli (colibacillosis) and bacterial pneumonia (shipping fever complex, pasteurellosis) caused by Pasteurella multocida.
Active Ingredient(s)
  • Oxytetracycline Hydrochloride
Marketing Category NADA - 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 NADA011060 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.

Terramycin Scours Images

Terramycin Scours 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



Terramycin Scours Tablets is an oral formulation containing oxytetracycline, a versatile, broad-spectrum antibiotic that possesses potent antimicrobial activity, for use in beef and dairy calves.


Indications And Usage



Terramycin Scours Tablets are recommended for oral administration for the control and treatment of the following diseases in beef and dairy calves caused by organisms sensitive to oxytetracycline: bacterial enteritis caused by Salmonella typhimurium and Escherichia coli (colibacillosis) and bacterial pneumonia (shipping fever complex, pasteurellosis) caused by Pasteurella multocida.


Warnings



Discontinue treatment at least 7 days prior to slaughter. Not for use in lactating dairy cattle. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.


Precautions



Exceeding the recommended dosage level of 2 tablets per 100 lb of body weight every 12 hours (10 mg/lb of body weight daily), or administering at this recommended level for more than 4 consecutive days, may result in antibiotic residues beyond the withdrawal time.

Organisms may vary in their degree of susceptibility to any chemotherapy. If no improvement is observed after recommended treatment, diagnosis and susceptibility should be reexamined.

Rarely do side reactions or allergic manifestations occur in calves treated with Terramycin. If any unusual reactions are noted, discontinue use of the drug immediately and call a veterinarian.

Since bacteriostatic drugs may interfere with the bacterial action of penicillin, it is advisable to avoid giving Terramycin in conjunction with penicillin.


Dosage And Administration



For control of bacterial enteritis and bacterial pneumonia orally administer 1 tablet per 100 lb of body weight every 12 hours (5 mg/ lb of body weight daily in divided doses) for up to 4 consecutive days.

For treatment of bacterial enteritis and bacterial pneumonia orally administer 2 tablets per 100 lb of body weight every 12 hours (10 mg/lb of body weight daily in divided doses) for up to 4 consecutive days.

Dosage should continue until the animal returns to normal and for 24–48 hours after symptoms have subsided. Treatment should not exceed 4 consecutive days.


Care Of Sick Animals



The use of antibiotics in the management of disease is based on an accurate diagnosis and an adequate course of treatment. When properly used in the treatment of diseases caused by oxytetracycline-susceptible organisms, most animals treated with Terramycin Scours Tablets show a noticeable improvement within 24–48 hours. If improvement does not occur within this period of time, the diagnosis and course of treatment should be reevaluated. It is recommended that the diagnosis and treatment of animal diseases be carried out by a veterinarian. Since many diseases look alike but require different types of treatment, the use of professional veterinary and laboratory services can reduce treatment time, costs, and needless losses. Good housing, sanitation, and nutrition are important in the maintenance of healthy animals and are essential in the treatment of disease.


Recommended Storage



Store below 25°C (77°F).


Principal Display Panel - 24 Tablet Bottle Label



40039319


Principal Display Panel - 100 Tablet Bottle Label



40039320


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.