TOLTRAMAX 5% SUSPENSION- toltrazuril 5% suspension liquid

Toltramax 5% suspension by

Drug Labeling and Warnings

Toltramax 5% suspension by is a Animal medication manufactured, distributed, or labeled by Vetr, LLC, Alivira Animal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

Keep out of reach of children. Recognized as safe for use in pregnant and lactating females and puppies & kittens over four weeks of age.

DOSAGE & ADMINISTRATION

Shake well before use. Dose at 1 mL (50 mg toltrazuril) per 5 pounds of body weight, for 3-5 consecutive days. Toltramax should be administered orally and retreatment may be necessary after  4-6 weeks.

STORAGE AND HANDLING

Store at room temperature (at or below 77F). Do not allow to freeze.

ACTIVE INGREDIENT

Toltrazuril USP, 5% suspension (50 mg/mL)

INACTIVE INGREDIENT

Glycerin USP, methyl- and propylparaben (preservative), purified water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOLTRAMAX 5% SUSPENSION 
toltrazuril 5% suspension liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86213-111
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLTRAZURIL (UNII: QVZ3IAR3JS) (TOLTRAZURIL - UNII:QVZ3IAR3JS)	TOLTRAZURIL	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	APPLE (UNFLAVORED)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86213-111-02	60 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/12/2025

TOLTRAMAX 5% SUSPENSION 
toltrazuril 5% suspension liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86213-112
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLTRAZURIL (UNII: QVZ3IAR3JS) (TOLTRAZURIL - UNII:QVZ3IAR3JS)	TOLTRAZURIL	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	APPLE (ALFALFA Flavored)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86213-112-01	60 mL in 1 BOTTLE, PLASTIC
2	NDC: 86213-112-02	120 mL in 1 BOTTLE, PLASTIC
3	NDC: 86213-112-04	500 mL in 1 BOTTLE, PLASTIC
4	NDC: 86213-112-05	960 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/12/2025

TOLTRAMAX 5% SUSPENSION 
toltrazuril 5% suspension liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86213-113
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLTRAZURIL (UNII: QVZ3IAR3JS) (TOLTRAZURIL - UNII:QVZ3IAR3JS)	TOLTRAZURIL	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	CHICKEN	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86213-113-01	60 mL in 1 BOTTLE, PLASTIC
2	NDC: 86213-113-02	120 mL in 1 BOTTLE, PLASTIC
3	NDC: 86213-113-03	240 mL in 1 BOTTLE, PLASTIC
4	NDC: 86213-113-04	500 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/12/2025

TOLTRAMAX 5% SUSPENSION 
toltrazuril 5% suspension liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86213-114
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLTRAZURIL (UNII: QVZ3IAR3JS) (TOLTRAZURIL - UNII:QVZ3IAR3JS)	TOLTRAZURIL	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	APPLE (PEANUT BUTTER Flavored)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86213-114-01	60 mL in 1 BOTTLE, PLASTIC
2	NDC: 86213-114-02	120 mL in 1 BOTTLE, PLASTIC
3	NDC: 86213-114-03	240 mL in 1 BOTTLE, PLASTIC
4	NDC: 86213-114-04	500 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/12/2025

Labeler - Vetr, LLC (132219984)

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

Establishment
Name	Address	ID/FEI	Business Operations
Alivira Animal Health		650916617	api manufacture