Label: CHLORTETRACYCLINE HYDROCHLORIDE powder, for solution
- NDC Code(s): 76475-236-01
- Packager: Quo Vademus
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Drug Label Information
Updated November 8, 2023
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SPL UNCLASSIFIED SECTION
NDC 76475-236-01
CHLORTETRACYCLINE HYDROCHLORIDE SOLUBLE POWDER
Antibiotic
For Use in Drinking Water of Chickens, Turkeys and Swine.
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
FOR VETERINARY USE ONLY
Restricted Drug(s) (California) Not for Human Use
Store at Controlled Room Temperature of 20° to 25°C (68° to 77°F). Brief exposure up to 40°C (104°F) may be tolerated.
Prepared fresh drinking water solutions daily.
For use in drinking water only.
Not for use in liquid feed supplements, milk or milk replacers.
Use as the sole source of drinking water.
KEEP OUT OF REACH OF CHILDREN
Safety Data Sheet (SDS) available.
Net Wt 725.8 g (25.6 oz)
Approved by FDA under ANADA # 200-236
Manufactured For:
Quo Vademus, LLC
Kenansville, NC 28349
customercare@quovademusllc.com • 910-296-1632 -
INDICATIONS FOR USE AND DOSAGE
CHICKENS
Control of infectious synovitis caused by M. synoviae - 200 to 400 mg chlortetracycline hydrochloride per gallon drinking water (5.0 - 13.4 mg/lb body weight per day). Control of chronic respiratory disease (CRD) and air sac infections caused by M. gallisepticum and E. coli - 400 to 800 mg chlortetracycline hydrochloride per gallon drinking water (10.0 - 26.8 mg/lb body weight per day).
TURKEYS
Control of infectious synovitis caused by M. synoviae - 400 mg chlortetracycline hydrochloride per gallon drinking water (3.2 - 16.8 mg/lb body weight per day). Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) - 25 mg chlortetracycline hydrochloride per pound body weight daily.
SWINE
Control and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp. and bacterial pneumonia associated with Pasteurella spp., Actinobacillus pleuropneumonia, Klebsiella spp. - 10 mg chlortetracycline hydrochloride per pound body weight daily in divided doses for 3 to 5 days.
- WARNING
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PRECAUTIONS
Prepare fresh drinking water solutions daily. In automatic watering systems, prepare fresh stock solutions every 6 hours. Solutions are not stable in galvanized containers; their use is not recommended. Drinking water solutions should not be stored at 40°C (104°F) for longer than 12 hours. Stock solutions should not be stored at 40°C (104°F) for longer than 3 hours. Use only against organisms sensitive to chlortetracycline. Use as the sole source of chlortetracycline. Do not mix in liquid feed supplements, milk or milk replacers. Administer 1 hour before or 2 hours after feeding with milk or milk replacers.
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DIRECTIONS FOR USE
Dissolve the contents of one packet of Chlortetracycline Hydrochloride Soluble Powder in four (4) gallons of water to prepare a stock solution, when metered at the rate of 1 oz of stock solution per gallon of drinking water, will deliver 200 mg chlortetracycline hydrochloride per gallon of drinking water. One level measuring teaspoon contains approximately 360 mg chlortetracycline hydrochloride which will treat 36 lbs (16 kg) of animal at 10 mg/lb for one day. Not to be used for more than 14 consecutive days in chickens and turkeys and five days in swine. The concentration of drug required in drinking water must be adjusted to provide a correct dosage in order to compensate for variations in the age of the animal, class of poultry, environmental temperature and humidity; each of which affects water consumption.
CHICKENS AND TURKEYS
Administer for 7 to 14 days. Medicate continuously at the first clinical signs of disease. The dosage range permitted provides for different levels based on the severity of the infection. As a generalization, 100 turkeys will drink one gallon of water per day for each week of age. Chickens will consume one half this amount.
- CONTENTS
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PRINCIPAL DISPLAY PANEL - 25.6 Ounce Packet
NDC 76475-236-01
CHLORTETRACYCLINE HYDROCHLORIDE SOLUBLE POWDER
Antibiotic
For Use in Drinking Water of Chickens, Turkeys and Swine.
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
FOR VETERINARY USE ONLY
Restricted Drug(s) (California) Not for Human Use
Store at Controlled Room Temperature of 20° to 25°C (68° to 77°F). Brief exposure up to 40°C (104°F) may be tolerated.
Prepared fresh drinking water solutions daily.
For use in drinking water only.
Not for use in liquid feed supplements, milk or milk replacers.
Use as the sole source of drinking water.
KEEP OUT OF REACH OF CHILDREN
Safety Data Sheet (SDS) available.
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Net Weight: 725.8 g (25.6 oz)
Approved by FDA under ANADA # 200-236
Manufactured For:
Quo Vademus, LLC
Kenansville, NC 28349
customercare@quovademusllc.com • 910-296-1632 -
Principal Display Panel - 25 pouch carton front display panel
NDC 76475-236-01
CHLORTETRACYCLINE HYDROCHLORIDE SOLUBLE POWDER
Antibiotic
For Use in Drinking Water of Chickens, Turkeys and Swine.
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
FOR VETERINARY USE ONLY
Restricted Drug(s) (California) Not for Human Use
Store at Controlled Room Temperature of 20° to 25°C (68° to 77°F). Brief exposure up to 40°C (104°F) may be tolerated.
For use in drinking water only.
Not for use in liquid feed supplements, milk or milk replacers.
Use as the sole source of drinking water.
KEEP OUT OF REACH OF CHILDREN
LOT NUMBER & EXPIRATION DATE
Net Weight: 25 x 725.8 grams (25.6 ounces)
Approved by FDA under ANADA # 200-236
Before using, read Safety Data Sheet (SDS) for the product.
Manufactured For:
Quo Vademus, LLC
Kenansville, NC 28349
customercare@quovademusllc.com • 910-296-1632 -
INGREDIENTS AND APPEARANCE
CHLORTETRACYCLINE HYDROCHLORIDE
chlortetracycline hydrochloride powder, for solutionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:76475-236 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORTETRACYCLINE HYDROCHLORIDE (UNII: O1GX33ON8R) (CHLORTETRACYCLINE - UNII:WCK1KIQ23Q) CHLORTETRACYCLINE HYDROCHLORIDE 64 g in 0.45 kg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76475-236-01 25 in 1 CARTON 1 .726 kg in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200236 09/09/2019 Labeler - Quo Vademus (038259713) Registrant - Quo Vademus (038259713) Establishment Name Address ID/FEI Business Operations Neogen Corporation - Mercer Rd. 042125879 manufacture Establishment Name Address ID/FEI Business Operations Particle Technology Labs 808076947 analysis