أمبروليوم

Chickens (broilers)

For increased rate of weight gain, improved feed efficiency and as an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur in broiler chickens raised in floor pens.

Do not feed to laying chickens. As sole source of amprolium and organic arsenic. Do not use as a treatment for outbreaks of coccidiosis. Feed as the sole ration from time chickens are placed litter until past the time when coccidiosis is ordinarily a hazard. Do not use in Type B or Type C medicated feeds containing bentonite.

Amprol HI-E® / BMD® / Roxarsone

Chickens (broilers)

As an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur; for increased rate of weight gain, improved feed efficiency, and improved pigmentation.

Feed continuously as the sole ration; as sole source of amprolium. Do not use in Type B or Type C medicated feeds containing bentonite.

Amprol HI-E® & Bambermycins

Chickens (broilers)

As an aid in prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur; for improved feed efficiency, and for improved pigmentation in broiler chickens.

Do not feed to laying chickens. Withdraw 5 days before slaughter. As sole source of amprolium and organic arsenic. Do not use as a treatment for outbreaks of coccidiosis. Feed as the sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use in Type B or Type C medicated feeds containing bentonite.

Amprol HI-E® / Baciferm® / 3-Nitro®

Chickens (broilers)

Where immunity to coccidiosis is not desired; prevention of coccidiosis; treatment of chronic respiratory disease caused by strains of Mycoplasma gallisepticum susceptible to chlortetracycline.

Feed continuously as sole ration for not more than the first 21 days of life. For use in feeds containing 0.8% calcium and 1.5% sodium sulfate. Do not use in medicated feeds containing bentonite. Do not feed to chickens producing eggs for human consumption.

Amprol Plus® and Aureomycin®

Chickens (broilers)

As an aid in prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur; improved feed efficiency.

Do not feed to laying chickens. Withdraw 5 days before slaughter. As sole source of amprolium and organic arsenic. Do not use as a treatment for outbreaks of coccidiosis. Feed as the sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use in Type B or Type C medicated feeds containing bentonite.

3-Nitro® / Albac® / Amprol Hi-E®

Chickens (broilers and replacements)

Where immunity to coccidiosis is not desired; to aid in prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur. For increased rate of weight gain in broiler chickens raised in floor pens.

Not for chickens over 16 weeks of age. Do not feed to laying chickens. As sole source of amprolium. Not for use as a treatment for outbreaks of coccidiosis. Feed as the sole ration from the time chickens are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use in Type B or Type C medicated feeds containing bentonite.

AMPROL Hi-E® and BMD®

Chickens (broilers and replacements)

Where immunity to coccidiosis is not desired; prevention of coccidiosis; treatment of chronic respiratory disease (air-sac infection), blue comb (nonspecific infectious enteritis).

Not for laying hens. Do not use in Type B or Type C medicated feeds containing bentonite.

Rainbrook Broiler Premix No.1

Chickens (broilers and replacements)

Where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation.

As sole source of organic arsenic. Not for laying hens. Do not use in Type B or Type C medicated feeds containing bentonite.

Amprol HI-E® / Roxarsone

Replacement chickens up to 5 weeks of age

For the development of active immunity to coccidiosis and for increased rate of weight gain and improved feed efficiency in replacement chickens up to 5 weeks of age and under conditions of moderate exposure to coccidiosis.

AMPROL® 25% and BMD®

Replacement chickens from 5 to 8 weeks of age

For the development of active immunity to coccidiosis and for increased rate of weight gain and improved feed efficiency in replacement chickens from 5 to 8 weeks of age and under conditions of moderate exposure to coccidiosis.

AMPROL® 25% and BMD®

Replacement chickens over 8 weeks of age

For the development of active immunity to coccidiosis and for increased rate of weight gain and improved feed efficiency in replacement chickens over 8 weeks of age.

AMPROL® 25% and BMD®

Chickens (Replacements: Up to 5 Weeks of Age))

For the development of active immunity to coccidiosis, as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in replacement chickens.

Feed continuously as sole ration under conditions of severe exposure to coccidiosis up to 5 weeks of age. Do not feed to laying chickens. Feed as sole source of organic arsenic. Feed as sole source of amprolium. Drug overdose or lack of water may result in leg weakness or paralysis. Do not use in feed containing bentonite.

3-Nitro® / Amprol® / BMD®

Chickens (Replacements: Up to 5 Weeks of Age)

For the development of active immunity to coccidiosis, as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in replacement chickens.

Feed continuously as sole ration under conditions of slight exposure to coccidiosis up to 5 weeks of age. Do not feed to laying chickens. Feed as sole source of organic arsenic. Feed as sole source of amprolium. Drug overdose or lack of water may result in leg weakness or paralysis. Do not use in feed containing bentonite.

3-Nitro® / Amprol® / BMD®

Chickens (Replacements: From 5 to 8 Weeks of Age)

For the development of active immunity to coccidiosis, as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in replacement chickens.

Feed continuously as sole ration under conditions of moderate exposure to coccidiosis from 5 to 8 weeks of age. Do not feed to laying chickens. Feed as sole source of organic arsenic. Feed as sole source of amprolium. Drug overdose or lack of water may result in leg weakness or paralysis. Do not use in feed containing bentonite.

3-Nitro® / Amprol® / BMD®

Chickens (Replacements: Over 8 Weeks of Age)

For the development of active immunity to coccidiosis, as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in replacement chickens.

Feed continuously as sole ration under conditions of moderate exposure to coccidiosis over 8 weeks of age. Do not feed to laying chickens. Feed as sole source of organic arsenic. Feed as sole source of amprolium. Drug overdose or lack of water may result in leg weakness or paralysis. Do not use in feed containing bentonite.

3-Nitro® / Amprol® / BMD®

Laying Hens

Treatment of coccidiosis.

No other source of drinking water should be available to the birds during this time. As sole source of amprolium.Make drinking water fresh daily. Stock solutions for proportioners may be stored in a clean, closed, labeled container for up to 3 days.

AMPROL® 128

Growing Chickens

Treatment of coccidiosis.

No other source of drinking water should be available to the birds during this time. As sole source of amprolium.Make drinking water fresh daily. Stock solutions for proportioners may be stored in a clean, closed, labeled container for up to 3 days.

AMPROL® 128

Broiler Chickens

As an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunette is likely to occur; for increased rate of weight gain; improved feed efficiency, and improved pigmentation

Feed continuously as the sole ration. As sole source of amprolium and organic arsenic. Withdraw 5 days before slaughter. Do not use in Type B or Type C medicated feeds containing bentonite.

3-Nitro® / Amprol / Flavomycin®

Broiler Chickens

Prevention of coccidiosis where immunity to coccidiosis is not desired and for increased rate of weight gain and improved feed efficiency in broiler chickens.

Feed continuously as the sole ration. Increasing levels of amprolium may not prevent coccidiosis caused by strains of Eimeria commonly found to be resistant to amprolium. Use 0.0125% amprolium for most field conditions as they exist under modern management practices. Where severe coccidiosis conditions exist and where immunity is not required, use 0.025% amprolium. Use as sole source of amprolium. Do not use in feeds containing bentonite. Do not change the litter while giving this feed unless absolutely necessary. If losses exceed 0.5% in a 2-day period, obtain an accurate diagnosis and follow the instructions of your veterinarian or poultry pathologist. Losses may result from intercurrent disease or other conditions affecting drug intake, which can contribute to the virulence of coccidiosis under field conditions.

Flavomycin® and Amprol®/ Amprol 25%® and Flavomycin®

Broiler Chickens

Prevention of coccidiosis caused by Eimena tenella only, and for increased rate of weight gain and improved feed efficiency in broiler chickens.

Feed continuously as the sole ration. Increasing levels of amprolium may not prevent coccidiosis caused by strains of Eimeria commonly found to be resistant to amprolium. Use as sole source of amprolium. Do not use in feeds containing bentonite. Do not change the litter while giving this feed unless absolutely necessary. If losses exceed 0.5% in a 2-day period, obtain an accurate diagnosis and follow the instructions of your veterinarian or poultry pathologist. Losses may result from intercurrent disease or other conditions affecting drug intake, which can contribute to the virulence of coccidiosis under field conditions.

Flavomycin® and Amprol®/ Amprol 25%® and Flavomycin®

Broiler Chickens

As an aid in the prevention of coccidiosis; for increased rate of weight gain; improved feed efficiency, and improved pigmentation.

Feed continuously as the sole ration. As sole source of amprolium and organic arsenic. Withdraw 5 days before slaughter. Do not use in Type B or Type C medicated feeds containing bentonite.

3-Nitro® / Amprol / Flavomycin®

Amprol Hi-E is intended for use as an aid in the prevention of coccidiosis where severe exposure to coccidiosis from E. acervulina, E. maxima and ,E. brunette is likely to occur. It is for use (1) in broiler chickens and (2) in replacement chickens where immunity to coccidiosis is not desired.

Not for chickens over 16 weeks of age. Use as sole source of amprolium. Do not use amprolium-ethopabate Type C medicated feed as a treatment for outbreaks of coccidiosis. Do not change the litter while giving this feed unless absolutely necessary. Do not use in feeds containing bentonite.

Amprol Hi-E

AMPROL PLUS (amprolium, ethopabate) is intended for use as an aid in the prevention of coccidiosis (1) In broiler chickens and (2) in replacement chickens where immunity to coccidiosis is not desired.

Use as sole source of amprolium. Do not use amprolium-ethopabate Type C medicated feed as a treatment for outbreaks of coccidiosis. Do not change the litter while giving this feed unless absolutely necessary. Do not use in feeds containing bentonite.

Amprol Plus

Chickens (Laying)

COCCIPROL 9.6% Oral Solution is intended for the treatment of coccidiosis in growing chickens, laying hens, and turkeys.

No other source of drinking water should be available to the birds during the treatment period. Use as the sole source of amprolium.

Cocciprol™

Chickens (Growing)

COCCIPROL 9.6% Oral Solution is intended for the treatment of coccidiosis in growing chickens, laying hens, and turkeys.

No other source of drinking water should be available to the birds during the treatment period. Use as the sole source of amprolium.

Cocciprol™

Chickens (Growing)

For the treatment of coccidiosis in growing chickens, turkeys, and laying hens.

Use as sole source of amprolium.

AmproMed™ P for Poultry

Chickens (boillers)

As an aid in the prevention of coccidiosis where severe exposure to Eimeria acervulina, E. brunetti, and E. maxima is likely to occur, for increased rate of weight gain and improved feed efficiency

Feed continuously as sole ration. Do not feed to laying hens. Not for chickens over 16 weeks of age. As sole source of amprolium. Do not use in Type B or Type C medicated feeds containing bentonite.

Amprol HI-E® / Stafac®

Chickens (Laying Hens)

For the treatment of coccidiosis in growing chickens, turkeys, and laying hens.

Use as sole source of amprolium.

AmproMed™ P for Poultry

Broiler chickens

For prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin; and for the prevention of coccidiosis where immunity to coccidiosis is not desired in broiler chickens.

Use as the sole source of amprolium. Do not use in feeds containing bentonite. Do not change the litter while giving this feed unless absolutely necessary. If losses exceed 0.5% in a 2-day period, obtain an accurate diagnosis and follow the instructions of your veterinarian or poultry pathologist. Losses may result from intercurrent disease or other conditions affecting drug intake, which can contribute to the virulence of coccidiosis under field conditions. Increasing levels of amprolium may not prevent coccidiosis caused by strains of Eimeria commonly found to be resistant to amprolium. Not for use in laying chickens. Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

Stafac® and AMPROL®

Broiler chickens

For prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin; and for the prevention of coccidiosis caused by E. tenella in broiler chickens.

For field conditions where only E. tenella is the major problem, feed continuously as the sole ration. Use as the sole source of amprolium. Do not use in feeds containing bentonite. Do not change the litter while giving this feed unless absolutely necessary. If losses exceed 0.5% in a 2-day period, obtain an accurate diagnosis and follow the instructions of your veterinarian or poultry pathologist. Losses may result from intercurrent disease or other conditions affecting drug intake, which can contribute to the virulence of coccidiosis under field conditions. Increasing levels of amprolium may not prevent coccidiosis caused by strains of Eimeria commonly found to be resistant to amprolium. Not for use in laying chickens. Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

Stafac® and AMPROL®

COCCIPROL 9.6% Oral Solution is intended for the treatment of coccidiosis in growing chickens, laying hens, and turkeys.

No other source of drinking water should be available to the birds during the treatment period. Use as the sole source of amprolium.

Cocciprol™

Aid in prevention of coccidiosis (Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis) and blackhead.

Feed continuously 2 weeks before coccidiosis and blackhead are expected and continue as long as prevention is needed. Withdraw 5 days before slaughter. Use as sole source of amprolium and organic arsenic. Do not use as a treatment for outbreaks of coccidiosis. Do not use in Type B or Type C medicated feeds containing bentonite.

Amprol® / Carb-O-Sep®

For prevention of coccidiosis; for increased rate of weight gain and improved feed efficiency.

Feed continuously as the sole source of amprolium.

Flavomycin® and Amprol®/ Amprol 25%® and Flavomycin®

For the treatment of coccidiosis in growing chickens, turkeys, and laying hens.

Use as sole source of amprolium.

AmproMed™ P for Poultry

Treatment of coccidiosis.

No other source of drinking water should be available to the birds during this time. As sole source of amprolium.Make drinking water fresh daily. Stock solutions for proportioners may be stored in a clean, closed, labeled container for up to 3 days.

AMPROL® 128

Cattle (calves)

As an aid in the prevention of coccidiosis caused by Eimeria bovis and E. zurnii.

Amprolium 9.6% Oral Solution

Cattle (Calves)

As an aid in the treatment of coccidiosis caused by Eimeria bovis and E. zurnii. in calves.

Corid 20% Soluble Powder

Beef and dairy calves

An aid in the treatment and prevention of coccidiosis caused by Eimeria bovis and E. zurnii in calves.

CocciAid® for Calves

Growing chickens, turkeys and laying hens

For the treatment of coccidiosis.

Use as sole source of amprolium. No other source of drinking water should be available to the birds during time of treatment. Make drinking water fresh daily.

Amprolium-P 9.6% Oral Solution

Growing chickens, turkeys, and laying hens

For the treatment of coccidiosis.

Use as the sole source of amprolium.

CocciAid®

INDICATIONS: Cocci-Cure® P FOR POULTRY (amprolium) 9.6% Oral Solution is intended for the treatment of coccidiosis in growing chickens, turkeys, and laying hens. If no improvement is noted within 3 days, have the diagnosis confirmed and follow the instructions of your veterinarian or poultry pathologist. Losses may result from intercurrent disease or other conditions affecting drug intake which can contribute to the virulence of coccidiosis under field conditions. USE DIRECTIONS: Give amprolium at the 0.012% level (8 fl oz per 50 gallons) as soon as coccidiosis is diagnosed and continue for three to five days. (In severe outbreaks, give amprolium at the 0.024% level). Continue with 0.006% amprolium medicated water for an additional 1 to 2 weeks. No other source of drinking water should be available to the birds during this time. Use as the sole source of amprolium.

FDA application 200-496

AmproMed™ P FOR POULTRY (amprolium) 9.6% Oral Solution Coccidiostat Water-soluble treatment for coccidiosis Treats 800 Gallons at 0.012% level. Restricted Drug (California) – Use Only as Directed Approved by FDA under ANADA # 200-496 Net Contents: 1 Gallon (128 fl oz) (3.785 L) Active Ingredient: amprolium..............9.6% INDICATIONS: AmproMed P FOR POULTRY (amprolium) 9.6 % Oral Solution is intended for the treatment of coccidiosis in growing chickens, turkeys, and laying hens. If no improvement is noted within 3 days, have the diagnosis confirmed and follow the instructions of your veterinarian or poultry pathologist. Losses may result from intercurrent disease or other conditions affecting drug intake which can contribute to the virulence of coccidiosis under field conditions.

FDA application 200-496

AmproMed™ FOR CALVES (amprolium) 9.6% Oral Solution Coccidiostat Restricted Drug (California) – Use Only as Directed Approved by FDA under ANADA # 200-482 Net Contents: 1 Gallon (128 fl oz) (3.785 L) Active Ingredient: amprolium..............9.6% INDICATIONS: An aid in the treatment and prevention of coccidiosis caused by Eimeria bovis and E. zuernii in calves. For a satisfactory diagnosis a microscopic examination of the feces should be done before treatment. When treating outbreaks, drug should be administered promptly after diagnosis is determined.

FDA application 200-482

USE DIRECTIONS: Give amprolium at the 0.012% level (10 oz AMPROL 128 20% Soluble Powder per 128 gallons) as soon as coccidiosis is diagnosed and continue for three to five days. (In severe outbreaks, give amprolium at the 0.024% level.) Continue with 0.006% amprolium medicated water for an additional 1 to 2 weeks. No other source of drinking water should be available to the birds during this time. Use as the sole source of amprolium. Restricted Drug (California) – Use Only as Directed.

FDA application 033-165

INDICATIONS FOR USE: AMPROL® (amprolium oral solution) 9.6% Oral Solution is intended for the treatment of coccidiosis in growing chickens, turkeys, and laying hens. If no improvement is noted within 3 days, have the diagnosis confirmed and follow the instructions of your veterinarian or poultry pathologist. Losses may result from intercurrent disease or other conditions affecting drug intake which can contribute to the virulence of coccidiosis under field conditions.

FDA application 013-149

INDICATIONS FOR USE: AMPROL® 25% (amprolium) Type A medicated article is intended for use in (1) preventing outbreaks of coccidiosis in growing chickens, turkeys, and pheasants and (2) development of active immunity to coccidiosis in replacement chickens. AMPROL 25% is also intended for use in the prevention and treatment of coccidiosis in laying chickens.

FDA application 012-350

INDICATIONS FOR USE: An aid in the treatment and prevention of coccidiosis caused by Eimeria bovis and E. zurnii in calves. For a satisfactory diagnosis a microscopic examination of the feces should be done before treatment. When treating outbreaks, drug should be administered promptly after diagnosis is determined.

FDA application 200-780

CORID® (amprolium soluble powder) 20% Soluble Powder - FOR ANIMAL USE ONLY INDICATIONS FOR USE: An aid in the treatment and prevention of coccidiosis caused by Eimeria bovis and E. zurnii in calves.

FDA application 033-165

CHICKENS As an aid in the treatment of caecal coccidiosis in growing chickens and laying birds. CALVES As an aid in the treatment of coccidiosis caused by Eimeria bovis and E. zuernii in calves.

DailyMed 5a015a95-7617-4961-b401-283698a0ee70

FOR ANIMAL USE ONLY INDICATIONS FOR USE: AMPROL® 128 (amprolium soluble powder) 20% Soluble Powder is intended for the treatment of coccidiosis in growing chickens, turkeys, and laying hens.

FDA application 033-165

INDICATIONS FOR USE: An aid in the prevention and treatment of coccidiosis caused by Eimeria bovis and E. zurnii in calves.

FDA application 012-350

To be used in the preparation of medicated feed to aid in the prevention and treatment of coccidiosis in calves.

FDA application 012-350

As an aid in the treatment and prevention of coccidiosis caused by Eimeria bovis and E. zuernii in calves

Do not use in calves to be processed for veal

AmproMed™ for Calves

As an aid in the prevention of coccidiosis caused by Eimeria bovis and E. zurnii

Boviprol™ 9.6% Oral Solution

WARNING: NOT FOR HUMAN USE. Keep this and all drugs out of reach of children. The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report adverse drug events, for technical assistance or to obtain a copy of the SDS, contact the manufacturer at 1-800-792-1238. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

FDA application 200-482

USER SAFETY WARNINGS: NOT FOR HUMAN USE. Keep this and all drugs out of the reach of children. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Aurora Pharmaceutical at 1-888-215-1256 or www.aurorapharmaceutical.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

FDA application 200-780

WARNING: NOT FOR HUMAN USE. Keep this and all drugs out of reach of children. The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report adverse drug events, for technical assistance or to obtain a copy of the 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 online at www.fda.gov/reportanimalae.

FDA application 200-482

WARNING: NOT FOR USE IN HUMANS. Keep this and all drugs out of the reach of children. FOR ORAL USE IN ANIMALS ONLY. MAY CAUSE EYE IRRITATION. For irritation, flush with water and seek medical attention. RESUDUE WARNING: Withdraw 24 h before slaughter. A withdrawl period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Vetr Ampromax (amprolium, 9.6% oral solution)

Treated calves must not be slaughtered for use in food for at least 7 days after the latest treatment with this drug. No withdrawal period is required for meat or eggs when chickens are treated according to the label. When handling the product, avoid oral exposure and direct contact with skin or eyes. Keep out of reach of children.

DailyMed 5a015a95-7617-4961-b401-283698a0ee70

USER SAFETY WARNINGS: NOT FOR HUMAN USE. Keep this and all drugs out of the reach of children. Contact Huvepharma Inc. at 1-877-994-4883 or http://www.huvepharma.us. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

FDA application 013-149

WARNING: Keep this and all drugs out of reach of children. NOT FOR HUMAN USE. PRECAUTIONS: FOR ORAL USE IN ANIMALS ONLY. MAY CAUSE EYE IRRITATION. For irritation, flush with plenty of water; get medical attention.

FDA application 200-496

WITHDRAWAL PERIODS AND RESIDUE WARNINGS: Withdraw 24 hours before slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

FDA application 012-350

NOT FOR HUMAN USE. Resticted Drug (California)- Use only as directed. Keep this and all drugs out of the reach of children.

FDA application 033-165

USER SAFETY WARNING: Keep this and all drugs out of the reach of children. NOT FOR HUMAN USE.

FDA application 013-149

WITHDRAWAL PERIODS: No withdrawal period is required when used according to labeling.

FDA application 012-350

WARNING: NOT FOR HUMAN USE. Keep this and all drugs out of reach of children.

FDA application 200-482

USER SAFETY WARNING: Not for Human Use. Keep out of reach of children.

FDA application 033-165

The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report adverse drug events, for technical assistance or to obtain a copy of the 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 online at www.fda.gov/reportanimalae.

FDA application 200-482

Contact Huvepharma Inc. at 1-877-994-4883 or http:/www.huvepharma.us. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae. AMPROL ® is a registered trademark of Huvepharma, Inc.

FDA application 033-165

Contact Huvepharma Inc. at 1-877-994-4883 or http://www.huvepharma.us. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

FDA application 013-149

Chickens (broilers)

113.5 grams per ton amprolium, 36.3 grams per ton ethopabate, and 4 to 50 grams per ton bacitracin (as feed grade bacitracin zinc) in Type C medicated feed. Feed as the sole ration from the time birds are placed on litter until past the time when coccidiosis is ordinarily a hazard, up to 16 weeks of age. If losses exceed 0.5% in a 2- day period, obtain an accurate diagnosis and follow the instructions of your veterinarian or poultry pathologist. Losses may result from intercurrent disease or other conditions affecting drug intake which can contribute to the virulence of coccidiosis under field conditions.

Oral

Not for chickens over 16 weeks of age. Do not feed as a treatment for outbreaks of coccidiosis. Do not change the litter while giving this feed unless absolutely necessary. Use as the sole source of amprolium. Do not use in feeds containing bentonite.

Amprol Hi-E® and Baciferm®

Chickens (broilers)

Amprolium 113.5 (0.0125 percent) grams per ton of feed and ethopabate 36.3 (0.004 percent) grams per ton of feed in combination with Bacitracin 10 to 50 grams per ton of feed plus roxarsone 15.4 to 45.4 (0.0017 percent to 0.005 percent) grams per ton of feed.

Oral

Do not feed to laying chickens. Withdraw 5 days before slaughter. As sole source of amprolium and organic arsenic. Do not use as a treatment for outbreaks of coccidiosis. Feed as the sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use in Type B or Type C medicated feeds containing bentonite.

3-Nitro® / Albac® / Amprol Hi-E®

Chickens (broilers)

Amprolium 113.5 (0.0125 percent) grams per ton of feed and ethopabate 36.3 (0.004 percent) grams per ton of feed, in combination with Bacitracin, 10 grams per ton of feed plus roxarsone 30 to 45.4 (0.0033 percent to 0.005 percent) grams per ton of feed.

Oral

Do not feed to laying chickens. Withdraw 5 days before slaughter. As sole source of amprolium and organic arsenic. Do not use as a treatment for outbreaks of coccidiosis. Feed as the sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use in Type B or Type C medicated feeds containing bentonite.

Amprol HI-E® / Baciferm® / 3-Nitro®

Chickens (broilers)

Bambermycins 1 to 3 grams per ton of feed plus amprolium, 113.5 grams (.0125 percent) per ton of feed plus ethopabate, 36.3 grams (.004 percent) per ton of feed plus roxarsone, 22.8 to 34.1 grams (.0025- .00375 percent) per ton of feed.

Oral

Feed continuously as the sole ration. As sole source of amprolium and organic arsenic. Withdraw 5 days before slaughter.

3-Nitro® / Amprol HI-E® / Flavomycin®

Chickens (broilers)

Amprolium 113.5 (0.0125 percent) grams per ton of feed and ethopabate 36.3 (0.004 percent) grams per ton of feed in combination with Bacitracin 20 to 35 grams per ton of feed plus roxarsone 34 (0.00375 percent) grams per ton of feed.

Oral

Do not feed to laying chickens. As sole source of amprolium and organic arsenic. Do not use as a treatment for outbreaks of coccidiosis. Feed as the sole ration from time chickens are placed litter until past the time when coccidiosis is ordinarily a hazard. Do not use in Type B or Type C medicated feeds containing bentonite.

Amprol HI-E® / BMD® / Roxarsone

Chickens (broilers)

Amprolium 113.5 (0.0125 percent) grams per ton of feed and ethopabate 36.3 (0.004 percent) grams per ton of feed in combination with Bambermycins, 1 to 3 grams per ton of feed.

Oral

Feed continuously as the sole ration; as sole source of amprolium. Do not use in Type B or Type C medicated feeds containing bentonite.

Amprol HI-E® & Bambermycins

Chickens (broilers)

227 grams amprolium, 3.6 grams ethopabate, and 200 grams chlortetracycline per ton of Type C medicated feed

Oral

Feed continuously as sole ration for not more than the first 21 days of life. For use in feeds containing 0.8% calcium and 1.5% sodium sulfate. Do not use in medicated feeds containing bentonite. Do not feed to chickens producing eggs for human consumption.

Amprol Plus® and Aureomycin®

Chickens (broilers and replacements)

Amprolium 113.5 to 227 (0.0125 percent to 0.025 percent) grams per ton of feed and ethopabate 3.6 (0.0004 percent) grams per ton of feed in combination with Roxarsone 22.7 to 45.4 (0.0025 percent to 0.005 percent) grams per ton of feed.

Oral

As sole source of organic arsenic. Not for laying hens. Do not use in Type B or Type C medicated feeds containing bentonite.

Amprol HI-E® / Roxarsone

Chickens (broilers and replacements)

Amprolium 113.5 to 227 (0.0125 percent to 0.025 percent) grams per ton of feed and ethopabate 3.6 (0.0004 percent) grams per ton of feed in combination with Penicillin plus streptomycin 90 to 180 (of combination) grams per ton of feed.

Oral

Not for laying hens. Do not use in Type B or Type C medicated feeds containing bentonite.

Rainbrook Broiler Premix No.1

Chickens (broilers and replacements)

Amprolium 113.5 to 227 (0.0125 percent to 0.025 percent) grams per ton of feed and ethopabate 3.6 (0.0004 percent) grams per ton of feed in combination with Arsanilic acid 90 (0.01 percent) grams per ton of feed.

Oral

As sole of organic arsenic. Not for laying hens. Do not use in Type B or Type C medicated feeds containing bentonite.

Rainbrook Broiler Premix No.1

Chickens (broilers and replacements)

Amprolium 113.5 (0.0125 percent) grams per ton of feed and ethopabate 36.3 (0.004 percent) grams per ton of feed in combination with Bacitracin 4 to 50 grams per ton of feed.

Oral

Not for chickens over 16 weeks of age. Do not feed to laying chickens. As sole source of amprolium. Not for use as a treatment for outbreaks of coccidiosis. Feed as the sole ration from the time chickens are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use in Type B or Type C medicated feeds containing bentonite.

AMPROL Hi-E® and BMD®

Replacement chickens up to 5 weeks of age

Amprolium: 72.6 to 113.5 g/ton; Bacitracin (as feed grade bacitracin methylenedisalicylate): 4 to 50 g/ton. Feed as sole ration under conditions of moderate exposure to coccidiosis up to 5 weeks of age.

Oral

AMPROL® 25% and BMD®

Replacement chickens from 5 to 8 weeks of age

Amprolium: 54.5 to 113.5 g/ton; Bacitracin (as feed grade bacitracin methylenedisalicylate): 4 to 50 g/ton. Feed as sole ration under conditions of moderate exposure to coccidiosis from 5 to 8 weeks of age.

Oral

AMPROL® 25% and BMD®

Replacement chickens over 8 weeks of age

Amprolium: 36.3 to 113.5 g/ton; Bacitracin (as feed grade bacitracin methylenedisalicylate): 4 to 50 g/ton. Feed as sole ration to replacement chickens over 8 weeks of age.

Oral

AMPROL® 25% and BMD®

Replacement chickens over 8 weeks of age

Amprolium: 36.3 to 113.5 g/ton Bacitracin methylene disalicylate: 4 to 50 g/ton

Oral

AMPROL® 25% and BMD®

Chickens (Replacements: Up to 5 Weeks of Age))

Amprolium: 113.5 g/ton Bacitracin methylene disalicylate: 50 g/ton Roxarsone: 22.7 to 45.4 g/ton

Oral

Feed continuously as sole ration under conditions of severe exposure to coccidiosis up to 5 weeks of age. Do not feed to laying chickens. Feed as sole source of organic arsenic. Feed as sole source of amprolium. Drug overdose or lack of water may result in leg weakness or paralysis. Do not use in feed containing bentonite.

3-Nitro® / Amprol® / BMD®

Chickens (Replacements: Up to 5 Weeks of Age)

Amprolium: 36.3 to 113.5 g/ton Bacitracin methylene disalicylate: 50 g/ton Roxarsone: 22.7 to 45.4 g/ton

Oral

Feed continuously as sole ration under conditions of slight exposure to coccidiosis up to 5 weeks of age. Do not feed to laying chickens. Feed as sole source of organic arsenic. Feed as sole source of amprolium. Drug overdose or lack of water may result in leg weakness or paralysis. Do not use in feed containing bentonite.

3-Nitro® / Amprol® / BMD®

Chickens (Replacements: From 5 to 8 Weeks of Age)

Amprolium: 54.5 to 113.5 g/ton Bacitracin methylene disalicylate: 50 g/ton Roxarsone: 22.7 to 45.4 g/ton

Oral

Feed continuously as sole ration under conditions of moderate exposure to coccidiosis from 5 to 8 weeks of age. Do not feed to laying chickens. Feed as sole source of organic arsenic. Feed as sole source of amprolium. Drug overdose or lack of water may result in leg weakness or paralysis. Do not use in feed containing bentonite.

3-Nitro® / Amprol® / BMD®

Chickens (Replacements: Over 8 Weeks of Age)

Amprolium: 36.3 to 113.5 g/ton Bacitracin methylene disalicylate : 50 g/ton Roxarsone: 22.7 to 45.4 g/ton

Oral

Feed continuously as sole ration under conditions of severe exposure to coccidiosis over 8 weeks of age. Do not feed to laying chickens. Feed as sole source of organic arsenic. Feed as sole source of amprolium. Drug overdose or lack of water may result in leg weakness or paralysis. Do not use in feed containing bentonite.

3-Nitro® / Amprol® / BMD®

Laying Hens

Administer at the 0.012 percent level in drinking water as soon as coccidiosis is diagnosed and continue for from 3 to 5 days (in severe outbreaks, give amprolium at the 0.024 percent level). Continue with 0.006 percent amprolium-medicated water for an additional 1 to 2 weeks.

Oral

No other source of drinking water should be available to the birds during this time. As sole source of amprolium.Make drinking water fresh daily. Stock solutions for proportioners may be stored in a clean, closed, labeled container for up to 3 days.

AMPROL® 128

Growing Chickens

Administer at the 0.012 percent level in drinking water as soon as coccidiosis is diagnosed and continue for from 3 to 5 days (in severe outbreaks, give amprolium at the 0.024 percent level). Continue with 0.006 percent amprolium-medicated water for an additional 1 to 2 weeks.

Oral

No other source of drinking water should be available to the birds during this time. As sole source of amprolium.Make drinking water fresh daily. Stock solutions for proportioners may be stored in a clean, closed, labeled container for up to 3 days.

AMPROL® 128

Broiler Chickens

Amprolium 113.5 (0.0125 percent) grams per ton of feed and ethopabate 36.3 (0.004 percent) grams per ton of feed, in combination with Bambermycins, 1 to 3 grams per ton of feed plus roxarsone 22.8 to 34.1 (0.0025 percent to 0.00375 percent) grams per ton of feed.

Oral

Feed continuously as the sole ration. As sole source of amprolium and organic arsenic. Withdraw 5 days before slaughter. Do not use in Type B or Type C medicated feeds containing bentonite.

3-Nitro® / Amprol / Flavomycin®

Broiler Chickens

113.5 (0.0125 percent) grams Amprolium per ton of feed in combination with Bambermycins, 1 to 3 grams per ton of feed, plus roxarsone 22.8 to 34.1 (0.0025 percent to 0.00375 percent) grams per ton of feed.

Oral

Feed continuously as the sole ration. As sole source of amprolium and organic arsenic. Do not use in Type B or Type C medicated feeds containing bentonite.

3-Nitro® / Amprol / Flavomycin®

Broiler Chickens

Amprolium: 72.6 to 113.5 g/ton (0.008 to 0.0125%) Bambermycins 1 to 2 g/ton

Oral

Feed continuously as the sole ration. Increasing levels of amprolium may not prevent coccidiosis caused by strains of Eimeria commonly found to be resistant to amprolium. Use as sole source of amprolium. Do not use in feeds containing bentonite. Do not change the litter while giving this feed unless absolutely necessary. If losses exceed 0.5% in a 2-day period, obtain an accurate diagnosis and follow the instructions of your veterinarian or poultry pathologist. Losses may result from intercurrent disease or other conditions affecting drug intake, which can contribute to the virulence of coccidiosis under field conditions.

Flavomycin® and Amprol®/ Amprol 25%® and Flavomycin®

Broiler Chickens

Amprolium: 113.5 to 227 g/ton (0.0125 to 0.025%) Bambermycins 1 to 2 g/ton

Oral

Feed continuously as the sole ration. Increasing levels of amprolium may not prevent coccidiosis caused by strains of Eimeria commonly found to be resistant to amprolium. Use 0.0125% amprolium for most field conditions as they exist under modern management practices. Where severe coccidiosis conditions exist and where immunity is not required, use 0.025% amprolium. Use as sole source of amprolium. Do not use in feeds containing bentonite. Do not change the litter while giving this feed unless absolutely necessary. If losses exceed 0.5% in a 2-day period, obtain an accurate diagnosis and follow the instructions of your veterinarian or poultry pathologist. Losses may result from intercurrent disease or other conditions affecting drug intake, which can contribute to the virulence of coccidiosis under field conditions.

Flavomycin® and Amprol®/ Amprol 25%® and Flavomycin®

Amprolium 113.5 (0.0125 percent) grams per ton and ethopabate 3.6 (0.0004 percent) grams per ton.

Not for chickens over 16 weeks of age. Use as sole source of amprolium. Do not use amprolium-ethopabate Type C medicated feed as a treatment for outbreaks of coccidiosis. Do not change the litter while giving this feed unless absolutely necessary. Do not use in feeds containing bentonite.

Amprol Hi-E

Chickens (Laying)

Give amprolium at the 0.012% level (8 fluid ounces per 50 gallons) for coccidiosis outbreaks as soon as coccidiosis is diagnosed and continue for 3 to 5 days. (In severe outbreaks, give amprolium at the 0.024% level). Continue with 0.006% amprolium medicated water for an additional 1 to 2 weeks.

Oral

No other source of drinking water should be available to the birds during the treatment period. Use as the sole source of amprolium.

Cocciprol™

Chickens (Growing)

Give amprolium at the 0.012% level (8 fluid ounces per 50 gallons) for coccidiosis outbreaks as soon as coccidiosis is diagnosed and continue for 3 to 5 days. (In severe outbreaks, give amprolium at the 0.024% level). Continue with 0.006% amprolium medicated water for an additional 1 to 2 weeks.

Oral

No other source of drinking water should be available to the birds during the treatment period. Use as the sole source of amprolium.

Cocciprol™

Chickens (Growing)

Give amprolium at the 0.012% level (8 fl oz AmproMed™ P for Poultry per 50 gallons) as soon as coccidiosis is diagnosed and continue for three to five days. (In severe outbreaks, give amprolium at the 0.024% level). Continue with 0.006% amprolium medicated water for an additional 1 to 2 weeks.

Oral

Use as sole source of amprolium.

AmproMed™ P for Poultry

Chickens (boillers)

Amprolium 113.5 (0.0125 percent) grams per ton of feed and ethopabate 36.3 (0.004 percent) grams per ton of feed in combination with Virginiamycin, 5 to 15 grams per ton of feed.

Oral

Feed continuously as sole ration. Do not feed to laying hens. Not for chickens over 16 weeks of age. As sole source of amprolium. Do not use in Type B or Type C medicated feeds containing bentonite.

Amprol HI-E® / Stafac®

Chickens (Laying Hens)

Give amprolium at the 0.012% level (8 fl oz AmproMed™ P for Poultry per 50 gallons) as soon as coccidiosis is diagnosed and continue for three to five days. (In severe outbreaks, give amprolium at the 0.024% level). Continue with 0.006% amprolium medicated water for an additional 1 to 2 weeks.

Oral

Use as sole source of amprolium.

AmproMed™ P for Poultry

Broiler chickens

20 grams virginiamycin and 72.6 to 113.5 grams amprolium per ton of Type C medicated feed.

Oral

For field conditions where only E. tenella is the major problem, feed continuously as the sole ration. Use as the sole source of amprolium. Do not use in feeds containing bentonite. Do not change the litter while giving this feed unless absolutely necessary. If losses exceed 0.5% in a 2-day period, obtain an accurate diagnosis and follow the instructions of your veterinarian or poultry pathologist. Losses may result from intercurrent disease or other conditions affecting drug intake, which can contribute to the virulence of coccidiosis under field conditions. Increasing levels of amprolium may not prevent coccidiosis caused by strains of Eimeria commonly found to be resistant to amprolium. Not for use in laying chickens. Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

Stafac® and AMPROL®

Give amprolium at the 0.012% level (8 fluid ounces per 50 gallons) for coccidiosis outbreaks as soon as coccidiosis is diagnosed and continue for 3 to 5 days. (In severe outbreaks, give amprolium at the 0.024% level). Continue with 0.006% amprolium medicated water for an additional 1 to 2 weeks.

Oral

No other source of drinking water should be available to the birds during the treatment period. Use as the sole source of amprolium.

Cocciprol™

Give amprolium at the 0.012% level (8 fl oz AmproMed™ P for Poultry per 50 gallons) as soon as coccidiosis is diagnosed and continue for three to five days. (In severe outbreaks, give amprolium at the 0.024% level). Continue with 0.006% amprolium medicated water for an additional 1 to 2 weeks.

Oral

Use as sole source of amprolium.

AmproMed™ P for Poultry

Administer at the 0.012 percent level in drinking water as soon as coccidiosis is diagnosed and continue for from 3 to 5 days (in severe outbreaks, give amprolium at the 0.024 percent level). Continue with 0.006 percent amprolium-medicated water for an additional 1 to 2 weeks.

Oral

No other source of drinking water should be available to the birds during this time. As sole source of amprolium.Make drinking water fresh daily. Stock solutions for proportioners may be stored in a clean, closed, labeled container for up to 3 days.

AMPROL® 128

113.5 to 227 (0.0125 percent to 0.025 percent) grams Amprolium per ton of feed in combination with Carbarsone 227 to 340.5 grams per ton.

Oral

Feed continuously 2 weeks before coccidiosis and blackhead are expected and continue as long as prevention is needed. Withdraw 5 days before slaughter. Use as sole source of amprolium and organic arsenic. Do not use as a treatment for outbreaks of coccidiosis. Do not use in Type B or Type C medicated feeds containing bentonite.

Amprol® / Carb-O-Sep®

Bambermycins, 1 to 4 grams per ton of feed plus amprolium, 113.5 grams (.0125 percent) per ton of feed.

Oral

Feed continuously as the sole source of amprolium.

Flavomycin® and Amprol®/ Amprol 25%® and Flavomycin®

Cattle (calves)

Administer 5 mg per kilogram (mg/kg) body weight in drinking water for 21 days during periods of exposure or when experience indicates that coccidiosis is likely to be a hazard.

Oral

Amprolium 9.6% Oral Solution

Cattle (calves)

Administer 10 mg/kg body weight in drinking water for 5 days.

Oral

Withdraw 24 hours before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Use as the sole source of amprolium.

Amprolium 9.6% Oral Solution

Cattle (Calves)

5 Day Treatment Protocol: Daily dosage 10 mg amprolium/kg (10 mg per 2.2 lb body weight)

Oral

Corid 20% Soluble Powder

Beef and dairy calves

Treatment Protocol: 10 mg/kg per day for 5 days in drinking water or as a drench. Prevention Protocol: 5 mg/kg per day for 21 days in drinking water or as a drench.

Oral

CocciAid® for Calves

Growing chickens, turkeys and laying hens

Administer at the 0.012 percent level in drinking water as soon as coccidiosis is diagnosed and continue for 3 to 5 days (in severe outbreaks, give amprolium at the 0.024 percent level); continue with 0.006 percent amprolium-medicated water for an additional 1 to 2 weeks.

Oral

Use as sole source of amprolium. No other source of drinking water should be available to the birds during time of treatment. Make drinking water fresh daily.

Amprolium-P 9.6% Oral Solution

Growing chickens, turkeys, and laying hens

Administer at the 0.012 percent level in drinking water as soon as coccidiosis is diagnosed and continue for 3 to 5 days (in severe outbreaks, give amprolium at the 0.024 percent level); continue with 0.006 percent amprolium-medicated water for an additional 1 to 2 weeks.

Oral

Use as the sole source of amprolium.

CocciAid®

MIXING DIRECTIONS AMPROL® 25% (amprolium) Type A medicated article should be thoroughly and evenly mixed in the feed. AMPROL 25% may be used to manufacture a Type C medicated feed in the concentration range of 0.004% to 0.025%. The table below shows the amount of AMPROL 25% to be used in each ton (2000 lb) of feed to obtain desired levels of amprolium in the Type C medicated feed. To aid in even distribution of AMPROL 25% in the finished feed, prepare a mixture of AMPROL 25% in a portion of complete feed ingredient before mixing into the finished ration. Blend the mixture with the remainder of the finished feed and mix thoroughly. Feeding level of Amprolium in Type C Medicated Feed Use This Amount of AMPROL 25% Per Ton 0.004% 5 oz. 0.006% 8 oz 0.008% 10 oz 0.0125% 1 lb 0.0175% 1 lb 6 ½ oz 0.025% 2 lb AMOUNT AND DIRECTIONS FOR USE CHICKENS Broilers: Prevention: Use 0.0125% amprolium Type C medicated feed continuously for most field conditions as they exist under modern management practices. Where severe coccidiosis conditions exists and where immunity is not required, use 0.025% amprolium Type C medicated feed. For field conditions where only E. tenella is the major problem, use 0.008%-0.0125% amprolium Type C medicated feed. Increasing levels of amprolium may not prevent coccidiosis caused by strains of Eimeria commonly found to be resistant to Amprolium. Replacements : Immunity Development or Prevention Prevention Program: Where immunity development is not desirable, use 0.0125%-0.025% amprolium Type C medicated feed continuously from day old until onset of production. Immunity Development Program: Use 0.004%-0.0125% amprolium Type C medicated feed continuously until onset of production. Selection of the level to be used should be based upon comparative hazard of infection with cecal and intestinal species. The higher levels will interfere with the development of immunity to E. tenella (cecal). The following are suggested feeding schedules for various conditions of coccidial exposure. The planning and evaluation of any program should be in the hands of a veterinarian or poultry pathologist who is familiar with the specific operation and with the general nature of disease problems in the area. 1. Severe exposure 2 . Moderate exposure 3 . Slight exposure 0-5 weeks of age 0.0125% 0-5 weeks of age 0.008%-0.0125% 0-5 weeks of age 0.004%-0.0125% 5-8 weeks of age 0.008%-0.0125% 5-8 weeks of age 0.006%-0.0125% 5-8 weeks of age 0.004%-0.0125% over 8 weeks of age 0.004%-0.0125% over 8 weeks of age 0.004%-0.0125% over 8 weeks of age 0.004%-0.0125% LAYING CHICKENS : Treatment: Use 0.025% amprolium Type C medicated feed for two weeks in severe outbreaks or 0.0125% amprolium Type C medicated feed for two weeks in moderate outbreaks. Prevention: Use 0.0125% amprolium Type C medicated feed continuously. TURKEYS : Prevention: Use 0.0125%-0.025% amprolium Type C medicated feed continuously. PHEASANTS : For the prevention of coccidiosis in growing pheasants caused by Eimeria colchici, E. duoden ali s, and E. phasiani . Type C medicated feed with 0.0175% amprolium should be fed continuously as the sole ration.

ORAL

FDA application 012-350

DOSAGE AND ADMINISTRATION: USE DIRECTIONS: 5 Day Treatment Protocol Daily Dosage: 10 mg amprolium/kg (10 mg per 2.2 lb body weight) 21 Day Prevention Protocol Daily Dosage: 5 mg amprolium/kg (5 mg per 2.2 lb body weight) USE DIRECTIONS: There are 96 mg of amprolium in every 1 mL of Cocci-Cure® C FOR CALVES. 1 fl oz = 29.57 mL 1 fl oz = 2 measuring tablespoons 8 fl oz = ½ pint (236.56 mL) 16 fl oz = 1 pint (473.12 mL) IN DRINKING WATER: Mix Cocci-Cure® C FOR CALVES 9.6% Oral Solution daily with fresh drinking water. 5-DAY TREATMENT: Add Cocci-Cure® C FOR CALVES 9.6% Oral Solution to drinking water at the rate of 16 fl oz/100 gal. At the usual rate of water consumption this will provide an intake of approximately 10 mg amprolium/kg (2.2 lb) body weight. Offer this solution as the only source of water for 5 days. Use on a herd basis only; when one or more calves show signs of coccidiosis, it is likely that the rest of the group has been exposed, and all calves in the group should be treated. 21-DAY PREVENTION: During periods of exposure or when experience indicates that coccidiosis is likely to be a hazard, add Cocci-Cure® C FOR CALVES 9.6% Oral Solution to drinking water at the rate of 8 fl oz/100 gal. At usual rates of water consumption, this will provide an intake of approximately 5 mg amprolium/kg (2.2 lb) body weight. Offer this solution as the only source of water for 21 days. AS A DRENCH: Cocci-Cure® C FOR CALVES 9.6% Oral Solution drench solutions may be stored in a clean, closed, labeled container for up to 3 days. 5-DAY TREATMENT: Add 3 fl oz Cocci-Cure® C FOR CALVES 9.6% Oral Solution to 1 pt of water and, with a dosage syringe, give 1 fl oz of this drench solution for each 100 lb (45 kg) body weight. This will provide a dose of approximately 10 mg amprolium/kg (2.2) body weight. Give daily for 5 days. Use on a herd basis only; when one or more calves show signs of coccidiosis, it is likely that the rest of the group has been exposed, and all calves should be treated. 21-DAY PREVENTION: During periods of exposure or when experience indicates that coccidiosis is likely to be a hazard, add 1 1/2 fl oz of Cocci-Cure® C FOR CALVES 9.6% Oral Solution to 1 pt of water and, with a dose syringe, give 1 fl oz of this solution for each 100 lb (45 kg) body weight. This will provide a dose of approximately 5 mg amprolium/kg (2.2 lb) body weight. Give daily for 21 days.

ORAL

FDA application 200-482

DOSAGE AND ADMINISTRATION: USE DIRECTIONS: There are 96 mg of amprolium in every 1 mL of Amprid FOR CALVES 5 Day Treatment Protocol 21 Day Prevention Protocol Daily Dosage: 10 mg amprolium/kg (10 mg per 2.2 lb body weight) Daily Dosage: 5 mg amprolium/kg (5 mg per 2.2 lb body weight) USE DIRECTIONS: There are 96 mg of amprolium in every 1 mL of Amprid FOR CALVES. 1 fl oz = 29.57 mL 1 fl oz = 2 measuring tablespoons 8 fl oz = ½ pint (236.56 mL) 16 fl oz = 1 pint (473.12 mL) IN DRINKING WATER: Mix Amprid FOR CALVES daily with fresh drinking water. 5-DAY TREATMENT: Add Amprid FOR CALVES 9.6% Oral Solution to drinking water at the rate of 16 fl oz/100 gal. At the usual rate of water consumption this will provide an intake of approximately 10 mg amprolium/kg (2.2 lb) body weight. Offer this solution as the only source of water for 5 days. Use on a herd basis only; when one or more calves show signs of coccidiosis, it is likely that the rest of the group has been exposed, and all calves in the group should be treated. 21-DAY PREVENTION: During periods of exposure or when experience indicates that coccidiosis is likely to be a hazard, add Amprid FOR CALVES 9.6% Oral Solution to drinking water at the rate of 8 fl oz/100 gal. At usual rates of water consumption, this will provide an intake of approximately 5 mg amprolium/kg (2.2 lb) body weight. Offer this solution as the only source of water for 21 days. AS A DRENCH: Amprid FOR CALVES drench solutions may be stored in a clean, closed, labeled container for up to 3 days. 5-DAY TREATMENT: Add 3 fl oz Amprid FOR CALVES 9.6% Oral Solution to 1 pt of water and, with a dosage syringe, give 1 fl oz of this drench solution for each 100 lb (45 kg) body weight. This will provide a dose of approximately 10 mg amprolium/kg (2.2) body weight. Give daily for 5 days. Use on a herd basis only; when one or more calves show signs of coccidiosis, it is likely that the rest of the group has been exposed, and all calves should be treated. 21-DAY PREVENTION: During periods of exposure or when experience indicates that coccidiosis is likely to be a hazard, add 1 1/2 fl oz of Amprid FOR CALVES 9.6% Oral Solution to 1 pt of water and, with a dose syringe, give 1 fl oz of this solution for each 100 lb (45 kg) body weight. This will provide a dose of approximately 5 mg amprolium/kg (2.2 lb) body weight. Give daily for 21 days.

ORAL

FDA application 200-482

MIXING DIRECTIONS: CORID 25% (amprolium) Type A medicated article should be thoroughly and evenly mixed in the feed. CORID 25% may be used to manufacture a Type B medicated feed with a concentration of 2.5% amprolium or a Type C medicated feed in the concentration range of 0.0125% to 1.25% amprolium. • Use 200 pounds of CORID 25% per ton of feed to produce Type B medicated feed containing 2.5% amprolium. • Use 1 pound of CORID 25% per ton of feed to produce Type C medicated feed containing 0.0125% amprolium.* • Use 100 pounds of CORID 25% per ton of feed to produce Type C medicated feed containing 1.25% amprolium. • Use 10 pounds of 2.5% Type B per ton of feed to produce Type C medicated feed containing 0.0125% amprolium. • Use 1000 pounds of 2.5% Type B per ton of feed to produce Type C medicated feed containing 1.25% amprolium. AMOUNT AND DIRECTIONS FOR USE: Prevention: 227 mg amprolium /100 lb (5 mg/kg) body weight per day for 21 days during periods of exposure or when experience indicates that coccidiosis is likely to be a hazard. Treatment: 454 mg amprolium/100 lb (10 mg/kg) bodyweight per day for 5 days. Use on a herd basis only; when one or more calves show signs of coccidiosis, it is likely that the rest of the group has been exposed and all calves in the group should be treated. *To aid in even distribution of CORID 25% in the finished feed, prepare a mixture of CORID 25% in a portion of complete feed ingredient before mixing into the finished ration. Blend the mixture with the remainder of the finished feed and mix thoroughly. The proper amount of amprolium supplement is mixed with the amount of ration consumed in one day. The tables below give suggested examples for using Type C medicated feed.

ORAL

FDA application 012-350

IN DRINKING WATER Mix CORID daily with fresh drinking water. Stock solution for water proportioners may be stored in a clean, closed, labeled container for up to 3 days. 5-DAY TREATMENT: Add CORID 20% Soluble Powder to drinking water at the rate of 4 oz/50 gal. One 10 oz pack to 125 gallons of water. For use in automatic water proportioners that meter 1 fl oz of stock solution per gallon of drinking water, add 1 bag (10 oz) in 1 gallon of water to make stock solution. At the usual rate of water consumption, this will provide an intake of approximately 10 mg amprolium/kg (2.2 lb) body weight. Offer this solution as the only source of water for 5 days. Treatment should be on a herd basis only; when one or more calves show signs of coccidiosis, it is likely that the rest of the group has been exposed, and all calves in the group should be treated. 21-DAY PREVENTION: During periods of exposure or when experience indicates that coccidiosis is likely to be a hazard, add CORID 20% Soluble Powder to drinking water at the rate of 4 oz/100 gal. One 10 oz pack to 250 gallons of water. For use in automatic water proportioners that meter 1 fl oz of stock solution per gallon of drinking water, add 1/2 bag (5 oz) in 1 gallon of water to make stock solution. At usual rates of water consumption, this will provide an intake of approximately 5 mg amprolium/kg (2.2 lb) body weight. Offer this solution as the only source of water for 21 days.

ORAL

FDA application 033-165

USE DIRECTIONS: Give amprolium at the 0.012% level (8 fl oz per 50 gallons) as soon as coccidiosis is diagnosed and continue for three to five days. (In severe outbreaks, give amprolium at the 0.024% level). Continue with 0.006% amprolium medicated water for an additional 1 to 2 weeks. No other source of drinking water should be available to the birds during this time. Use as the sole source of amprolium. FOR ANIMAL USE ONLY To prepare 50 Gallons of Medicated Water DOSAGE LEVEL MIXING DIRECTIONS 0.024 % Add 1 pint (16 fluid ounces) of AmproMed P FOR POULTRY (amprolium) 9.6% Oral Solution in about 5 gallons of water in a 50-gallon medication barrel. Stir, then add water to the 50-gallon mark. Stir thoroughly. 0.012 % Follow same directions as above but use 1/2 pint (8 fluid ounces) of AmproMed P FOR POULTRY 9.6% Oral Solution. 0.006 % Follow same directions as above but use 4 fluid ounces of AmproMed P FOR POULTRY 9.6% Oral Solution. For Automatic Water Portioners For automatic water proportioners that meter 1 fluid ounce of stock solution per gallon of drinking water. DOSAGE LEVEL AmproMed P FOR POULTRY 9.6 % ORAL SOLUTION PER GALLON OF STOCK SOLUTION 0.024 % 41 fl oz 0.012 % 20.5 fl oz 0.006 % 10.25 fl oz Note:Make drinking water fresh daily. Stock solutions for proportioners may be stored in a clean, closed labeled container for up to 3 days.

ORAL

FDA application 200-496

AS A DRENCH CORID drench solutions may be stored in a clean, closed, labeled container for up to 3 days. 5-DAY TREATMENT: Add 3 oz CORID 20% Soluble Powder to 1 qt (32 fl oz) of water and, with a dose syringe, give 1 fl oz of this solution for each 100 lb (45 kg) body weight. This will provide a dose of approximately 10 mg amprolium/kg (2.2 lb) body weight. Give daily for 5 days. Treatment should be on a herd basis only; when one or more calves show signs of coccidiosis, it is likely that the rest of the group has been exposed, and all calves in the group should be treated. 21-DAY PREVENTION: During periods of exposure or when experience indicates that coccidiosis is likely to be a hazard, add 1 1/2 oz of CORID 20% Soluble Powder to 1 qt (32 fl oz) of water and, with a dose syringe, give 1 fl oz of this solution for each 100 lb (45 kg) body weight. This will provide a dose of approximately 5 mg amprolium/kg (2.2 lb) body weight. Give daily for 21 days.

ORAL

FDA application 033-165

FOR ANIMAL USE ONLY To Prepare 50 Gallons of Medicated Water DOSAGE LEVEL MIXING DIRECTIONS 0.024% Add 1 pint (16 fluid ounces) of CocciAid​® (amprolium oral solution) 9.6% Oral Solution to about 5 gallons of water in a 50-gallon medication barrel. Stir, then add water to the 50-gallon mark. Stir thoroughly. 0.012% Follow same directions as above but use 1/2 pint (8 fluid ounces) of CocciAid​® 9.6% Oral Solution. 0.006% Follow same directions as above but use 4 fluid ounces of CocciAid​® 9.6% Oral Solution. For Automatic Water Proportioners For automatic water proportioners that meter 1 fluid ounce of stock solution per gallon of drinking water. DOSAGE LEVEL COCCIAID® 9.6% ORAL SOLUTION PER GALLON OF STOCK SOLUTION 0.024% 0.012% 0.006% 41 fl oz 20.5 fl oz 10.25 fl oz Note: Make drinking water fresh daily. Stock solutions for proportioners may be stored in a clean, closed labeled container for up to 3 days.

ORAL

FDA application 200-630

PREMEASURED FOR AUTOMATIC WATER PROPORTIONERS For Automatic Water Proportioners For use in automatic water proportioners that meter 1 fluid ounce of stock solution per gallon of drinking water. To prepare dosage levels of: Dissolve AMPROL 128 (amprolium soluble powder) 20% Soluble Powder in one gallon of water. (Makes 1 gallon of stock solution.) 0.024% 2 bags (20 oz) in 1 gallon 0.012% 1 bag (10 oz) in 1 gallon 0.006% ½ bag (5 oz) in 1 gallon To Prepare 50 Gallons of Medicated Water DOSAGE LEVEL MIXING DIRECTIONS 0.024% Dissolve 8 ounces of AMPROL 128 20% Soluble Powder in about 5 gallons of water in a 50-gallon medicated barrel. Stir, then add water to the 50-gallon mark. Stir thoroughly. 0.012% Follow same directions as above but use 4 ounces of AMPROL 128 20% Soluble Powder. 0.006% Follow same directions as above but use 2 ounces of AMPROL 128 20% Soluble Powder.

ORAL

FDA application 033-165

DOSAGE AND ADMINISTRATION: 5-Day Treatment Protocol 21-Day Prevention Protocol Daily Dosage: 10 mg amprolium/kg Daily Dosage: 5 mg amprolium/kg (10 mg per 2.2 lb body weight) (5 mg per 2.2 lb body weight) USE DIRECTIONS: There are 96 mg of amprolium in every 1 mL of CocciAid for Calves 9.6% Solution. 1 fl oz = 29.57 mL 8 fl oz = 1/2 pint (236.56 mL) 1 fl oz = 2 measuring tablespoons 16 fl oz = 1 pint (473.12 mL)

ORAL

FDA application 200-780

To prepare 200 L of medicated water DOSAGE MIXING DIRECTIONS 0.024% Add 500 mL of CocciAid​® (amprolium) 9.6% Solution to about 25 L of water in a 200 L medication barrel. Stir, then add water to the 200 L mark. Stir thoroughly. 0.012% Follow same directions as above but use 250 mL of CocciAid​® 9.6% Solution. 0.006% Follow same directions as above but use 125 mL of CocciAid​® 9.6% Solution.

ORAL

DailyMed 5a015a95-7617-4961-b401-283698a0ee70

FOR ANIMAL USE ONLY To prepare 50 Gallons of Medicated Water For Automatic Water Proportioners For automatic water proportioners that meter 1 fluid ounce of stock solution per gallon of drinking water. Note: Make drinking water fresh daily. Stock solutions for proportioners may be stored in a clean, closed labeled container for up to 3 days.

ORAL

FDA application 200-496

DOSAGE AND ADMINISTRATION: 5-Day Treatment Protocol 21-Day Prevention Protocol Daily Dosage: 10 mg amprolium/kg Daily Dosage: 5 mg amprolium/kg (10 mg per 2.2 lb body weight) (5 mg per 2.2 lb body weight)

ORAL

FDA application 013-149

Administer 5 mg per kilogram (mg/kg) body weight in drinking water for 21 days during periods of exposure or when experience indicates that coccidiosis is likely to be a hazard

Oral

Boviprol™ 9.6% Oral Solution

Prevention: 5 mg/kg per day for 21 days in drinking water or as a drench. Treatment: 10 mg/kg per day for 5 days in drinking water or as a drench.

Oral

Do not use in calves to be processed for veal

AmproMed™ for Calves

Administer 10 mg/kg body weight in drinking water for 5 days

Oral

Do not use in calves to be processed for veal. Use as the sole source of amprolium

Boviprol™ 9.6% Oral Solution