Animal NDC 61133-8251-3 Ampromed For Calves
Amprolium

Animal Product Information

Field Name Field Value
Animal NDC Code 61133-8251-3
Proprietary Name Ampromed For Calves 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 Amprolium 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 Bimeda Inc.
Product Type Otc Animal Drug
Usage Information
    AmproMed™ FOR CALVES(amprolium)9.6% Oral Solution CoccidiostatRestricted Drug (California) – Use Only as DirectedApproved by FDA under ANADA # 200-482Net 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.
Active Ingredient(s)
  • Amprolium
Marketing Category ANADA - ABBREVIATED 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 ANADA200482 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.

Ampromed For Calves Images

Ampromed For Calves 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



Indications & Usage



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.


Dosage & Administration



DOSAGE AND ADMINISTRATION:

 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 AmproMed 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 AmproMed FOR CALVES daily with fresh drinking water.

5-DAY TREATMENT: Add AMPROMED FOR CALVES 9.6% Oral Solution 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 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: AMPROMED 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 AMPROMED FOR CALVES 9.6% Oral Solution to 1 pt  of water and, with a dose 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 lb) 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 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.


Residue Warning



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.


Warnings



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


Precautions



PRECAUTIONS: FOR ORAL USE IN ANIMALS ONLY. MAY CAUSE EYE IRRITATION. For irritation, flush with plenty of water; get medical attention. 


Adverse Reactions



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.


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.

Sodium Benzoate 0.1% add as preservative.


Other



Manufactured by:

Bimeda, Inc.

Le Sueur, MN 56058


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