AMPROMAX- amprolium oral solution solution

Ampromax by

Drug Labeling and Warnings

Ampromax by is a Animal medication manufactured, distributed, or labeled by Vetr LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

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.

INSTRUCTIONS FOR USE

Shake well before use.

5 Day Regimen(coccidiosis symptoms present): Add Ampromax (9.6% amprolium) oral solution to drinking water at the rate of 16 fl oz/100 gal (473 mL/378.5 mL). At the usual rate of water consumption, this will provide intake of approximately 10 mg amprolium/kg body weight (2.2 lbs). 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 should be treated.

21 Day Regimen(coccidiosis exposure risk): During periods of exposure, or when experience indicates environmental coccidiosis risk, add Ampromax (9.6% amprolium) oral solution to drinking water at the rate of 8 fl oz/100 gal (237 mL/378.5 mL). At usual rates of consumption, this will provide approximately 5 mg amprolium/kg body weight (2.2 lbs). Offer this solution as the only source of water for 21 days.

STORAGE AND HANDLING

Store at room temperature, at or below 25 C (<77 F)

ACTIVE INGREDIENT

Amprolium USP, 96 mg/mL (9.6% w/v)

INACTIVE INGREDIENT

Purified water, preservative.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AMPROMAX 
amprolium oral solution solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86213-772
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMPROLIUM (UNII: 95CO6N199Q) (AMPROLIUM ION - UNII:H2T307KMZR)	AMPROLIUM	96 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86213-772-01	500 mL in 1 BOTTLE, PLASTIC
2	NDC: 86213-772-02	3785.4 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/09/2025

Labeler - Vetr LLC (132219984)

Establishment
Name	Address	ID/FEI	Business Operations
Vetr LLC		132219984	manufacture, label