AmproMed FOR CALVES

Manufacturer
Bimeda Inc. | Bimeda, Inc.
Effective date
2022-07-05
Label type
OTC ANIMAL DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 02:41:28

Label at a glance#

ProductAmproMed FOR CALVES
Active ingredientAMPROLIUM
Label structure9 sections

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.

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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 SECTION

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 SECTION

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 SECTION

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

PRECAUTIONS SECTION

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

ADVERSE REACTIONS SECTION

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 SECTION

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.

SPL UNCLASSIFIED SECTION

Manufactured by:

Bimeda, Inc.

Le Sueur, MN 56058

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092546amprolium 9.6 % Oral SolutionPSN14
1429033amprolium 96 MG/ML Oral Solution [AmproMed for Calves]SBD14
1092546amprolium 96 MG/ML Oral SolutionSCD14
1092546amprolium 9.6 % Oral SolutionSY14
1429033AmproMed for Calves 9.6 % Oral SolutionSY14
1429033AmproMed for Calves 96 MG/ML Oral SolutionSY14

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61133-8251-3AmproMed FOR CALVES3785 mL in 1 JUGSOLUTION378514
61133-8251-4AmproMed FOR CALVES473 mL in 1 BOTTLESOLUTION47314

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61133-8251AMPROMED FOR CALVES (AMPROLIUM) SOLUTION [BIMEDA INC.]142 package rows20220706_65dfe2b4-982d-4ffe-acad-165a50de6d0b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AMPROLIUMACTIVE INGREDIENT95CO6N199Q8
AMPROLIUM IONACTIVE MOIETYH2T307KMZR8

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61133-825161133-8251-3, 61133-8251-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMPROLIUM95CO6N199QACTIM

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.