Label: PENNCHLOR 64- chlortetracycline hydrochloride powder
- NDC Code(s): 51429-064-01
- Packager: Pharmgate Animal Health
- Category: PRESCRIPTION ANIMAL DRUG LABEL
Drug Label Information
Updated October 26, 2022
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RESIDUE WARNING
RESIDUE WARNINGS
Do not administer to chickens within 24 hours of slaughter. Do not use in laying chickens. Do not administer to growing turkeys within 24 hours of slaughter. Zero day withdrawal in swine. Do not administer to cattle within 24 hours of slaughter. Do not use in lactating dairy cattle. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal.
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DOSAGE & ADMINISTRATION
GENERAL INFORMATION ON DOSAGE
Dosages in terms of packets per 512 gallons are based on stated dosages per unit of body weight and average water consumption of the species. Weather conditions, ambient temperature, humidity, age, class of livestock and other factors may affect consumption and, except where calves are drenched, the unit dosage should be used as a guide to effective use in drinking water. Animals must actually consume enough medicated water to provide the desired therapeutic dose under the conditions that prevail.
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PRECAUTIONS
Use as the sole source of chlortetracycline. Prepare fresh solutions daily. When used in plastic or stainless steel waterers or automatic waterers, prepare fresh solutions every 24 hours. This product has not been demonstrated to provide adequate stability in galvanized waterers. Stability loss may reduce effectiveness of the product. Do not administer in milk or milk replacers. When feeding milk or milk replacers, administration one hour before or two hours after feeding is recommended.
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VETERINARY INDICATIONS
Indications and Directions For Use
Chickens Dose Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline. 200-400 mg/gal (1-2 packets/512 gallons). This is equivalent to ¼ - ½ oz of powder per 5 gallons of water. Mix until dissolved. Administer at the indicated rates in the total water consumed over a full 24-hour period. Administer 7 to 14 days. Control of Chronic Respiratory Disease (CRD) and air-sac infections caused by Mycoplasma gallisepticum and Escherichia coli susceptible to chlortetracycline. 400-800 mg/gal (2-4 packets/512 gallons). This is equivalent to ½ - 1 oz of powder per 5 gallons of water. Mix until dissolved. Administer at the indicated rates in the total water consumed over a full 24-hour period. Administer 7 to 14 days. Control of mortality due to fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline. 1000 mg/gal (5 packets/512 gallons). This is equivalent to ¼ oz of powder per 1 gallon of water. Mix until dissolved. Administer at the indicated rates in the total water consumed over a full 24-hour period. Administer 7 to 14 days. Growing Turkeys Dose Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline. 400 mg/gal (2 packets/512 gallons). This is equivalent to ½ oz of powder per 5 gallons of water. Mix until dissolved. Administer at this rate in the total water consumed over a full 24-hour period. Administer 7 to 14 days. Control of complicating bacterial organisms associated with Bluecomb (transmissible enteritis or coronaviral enteritis) susceptible to chlortetracycline. 25 mg/lb body weight/day (1 packet for every 4,096 lbs of turkeys). ⅛ oz treats a 20 lb turkey for one day. Mix until dissolved. Administer in the total water consumed over a full 24 hour period. Administer 7 to 14 days. Medicate chickens and turkeys continuously at the first clinical signs of disease and continue for 7 to 14 consecutive days. The dosage ranges permitted provide for different levels based on the severity of the infection. If improvement is not noted in 24-48 hours, consult a veterinarian or a diagnostic laboratory to determine diagnoses and for advice regarding the optimal level of the drug where ranges are permitted.
Swine Dose – 10 mg/pound body weight daily Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and Salmonella spp. and bacterial pneumonia associated with Pasturella spp., Actinobacillus pleuropneumoniae, and Klebsiella spp. susceptible to chlortetracycline. (5 packets/512 gallons will treat 512 100-lb pigs per day). ¼ oz of powder will treat a 100 lb pig for one day. Mix until dissolved. Administer at this rate in the total water consumed over a full 24-hour period. Administer for 3 to 5 days. Calves, Beef Cattle and Non-Lactating Dairy Cattle Dose – 10 mg/pound body weight daily Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and Salmonella spp. and bacterial pneumonia associated with Pasturella spp., Histophilus spp., and Klebsiella spp. susceptible to chlortetracycline. Use ½ oz. of powder for each 200 lbs of calf weight, per day. Mix until dissolved. Administer at this rate in the total water consumed over a full, 24-hour period, or as a drench in divided doses. Administer 3 to 5 days. Water Medicators: Dissolve the contents of one 25.6 oz packet in 100 oz of fresh water to prepare a stock solution, that when metered at the rate of 1 oz per gallon of drinking water, will deliver 1000 mg of chlortetracycline HCl per gallon. At this rate, a gallon of drinking water will treat a 100 lb pig or a 100 lb calf at the rate of 10 mg per lb of body weight for one day.
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SPL UNCLASSIFIED SECTION
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
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PRINCIPAL DISPLAY PANEL - 725.7 g Packet Label
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Pennchlor 64®
(chlortetracycline HCl)
Soluble Powder ConcentrateCAUTION: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.Antibiotic
For Animal Use in Drinking Water
Chlortetracycline hydrochloride, 64 g per poundThis 25.6 oz packet contains 102.4 g
chlortetracycline HCl (64 g/lb) and will
make the resulting concentrations:Gallons Chlortetracycline HCl
per Gallon1024 100 mg 512 200 mg 256 400 mg 102.4 1000 mg Net Contents: 25.6 oz (725.7 g)
Approved by FDA under ANADA #200-295
Not for Use in Humans.
Store at controlled room temperature 15°C to 30°C
(59°F to 86°F)
#F64-1 Rev. 6/22Pharmgate
ANIMAL HEALTHMarketed by:
Pharmgate Animal Health, LLC
14040 Industrial Road
Omaha, Nebraska 68144
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INGREDIENTS AND APPEARANCE
PENNCHLOR 64
chlortetracycline hydrochloride powderProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:51429-064 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlortetracycline Hydrochloride (UNII: O1GX33ON8R) (Chlortetracycline - UNII:WCK1KIQ23Q) Chlortetracycline Hydrochloride 0.141 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51429-064-01 725.7 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200295 04/27/2001 Labeler - Pharmgate Animal Health (833270817) Registrant - Pharmgate Inc. (079628671)