Label: AMPROMED FOR CALVES- amprolium solution
- NDC Code(s): 61133-8251-3
- Packager: Bimeda Inc., Division of Cross Vetpharm Group
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- INDICATIONS & USAGE
AmproMed™ FOR CALVES
9.6% Oral Solution
FOR ORAL USE IN ANIMAL ONLY
KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN
Restricted Drug (California) – Use Only as Directed
ANADA 200-482, Approved by FDA
1Gallon (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.
- DOSAGE & ADMINISTRATION
DOSAGE AND ADMINISTRATION:
USE DIRECTIONS: There are 96 mg of Amprolium in every 1 ml of AmproMed™ FOR CALVES
5 Day Treatment Protocol 21 Day Prevention Protocol
Daily Dosage: 10 mg Amprolium/kg
(10 mg per 2.2 lb body weight)
1 fl oz = 29.57 mL
1 fl oz = 2 measuring tablespoonfuls
Daily Dosage: 5 mg Amprolium/kg
(5 mg per 2.2 lb body weight)
8 fl oz = ½ pint (236.56 mL)
16 fl oz = 1 pint (473.12 mL)
IN DRINKING WATER
Mix AmproMed™ FOR CALVES daily with fresh drinking water.
5-DAY TREATMENT: Add AMPROMED™ FOR CALVES to drinking water at the rate of 16 fl oz/100 gallon. 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 AMPROMED™ FOR CALVES to drinking water at the rate of 8 fl oz/100 gallon. 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: AMPROMED™ FOR CALVES drench solutions may be stored in a clean, labeled container for up to 3 days.
5-DAY TREATMENT: Add 3 fl oz AMPROMED™ FOR CALVES to 1 pt (16 oz) 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 AMPROMED™ FOR CALVES to 1 pt (16 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.Close
- RESIDUE WARNING
RESIDUE WARNING: 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.Close
WARNING: Not for Human Use. Keep this and all drugs out of reach of children.
The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse reaction in users, to obtain more information, or to obtain a MSDS contact Bimeda at 1-888-524-6332.Close
PRECAUTIONS:MAY CAUSE EYE IRRITATION. For irritation, flush with plenty of water; get medical attention. Sodium Benzoate 0.1% add as preserve.Close
- STORAGE AND HANDLING
STORAGE: Store container in an upright position. Store between 5°C - 25°C (41°F - 77°F), with brief excursions to 40°C.Close
- INGREDIENTS AND APPEARANCE
AMPROMED FOR CALVES
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:61133-8251 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMPROLIUM (UNII: 95CO6N199Q) (AMPROLIUM ION - UNII:H2T307KMZR) AMPROLIUM ION 96 mg in 1 mL Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61133-8251-3 3785 mL in 1 JUG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200482 07/30/2012 Labeler - Bimeda Inc., Division of Cross Vetpharm Group (060492923) Registrant - Bimeda, Inc., Division of Cross Vetpharm Group (060492923) Establishment Name Address ID/FEI Business Operations Bimeda, Inc., Division of Cross Vetpharm Group 060492923 manufacture Establishment Name Address ID/FEI Business Operations Zhejiang Jiuzhou 654682061 api manufacture