Animal NDC 61133-8251-4 Ampromed For Calves

Amprolium

Animal NDC Product Code 61133-8251-4

Field Name Field Value
Animal NDC Code 61133-8251-4
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
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 Animal Product Label 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.

Product Labeling Index

Indications & Usage

AmproMed™ FOR CALVES(amprolium)9.6% Oral SolutionCoccidiostatFOR ORAL USE IN ANIMALS ONLYKEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDRENRestricted Drug (California) – Use Only as DirectedANADA 200-482, Approved by FDANet 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:USE DIRECTIONS: There are 96 mg of Amprolium in every 1 mL of AmproMed™ FOR CALVES 5 Day Treatment Protocol 21 Day Prevention ProtocolDaily Dosage: 10 mg amprolium/kg(10 mg per 2.2 lb body weight)1 fl oz = 29.57 mL1 fl oz = 2 measuring tablespoonfulsDaily 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.

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.

Warnings

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.

Precautions

PRECAUTIONS: MAY CAUSE EYE IRRITATION. For irritation, flush with plenty of water; get medical attention. Sodium Benzoate 0.1% add as preservative.

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.

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