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Tozal Prescribing Information

Package insert / product label
Generic name: vitamin a palmitate, ascorbic acid, cholecalciferol, alpha-tocopherol, pyridoxine hydrochloride, folic acid, cyanocobalamin, zinc picolinate, copper, omega-3 fatty acids, taurine, lutein and zeaxanthin
Dosage form: capsule, gelatin coated
Drug class: Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Mar 25, 2024.

15821-501-90 TOZALComplete Eye Health Formula

Actilease

for better absorption

Actilease

for better absorption

Dispense by Prescription

Medical Food

90 Softgels

TOZAL GLUTEN FEE

Tozal Description

TOZAL is an orally administered Medical Food specially formulated for the Dietary Managment of Age Related Macular Degneration, Dry Eye Syndrome and Meibomian Gland Dysfunction. TOZAL is intended to be used under the supervision of a doctor.

Indications and Usage for Tozal

TOZAL is indicated for the distinct nutritional requirements of individuals diagnosed with, or at risk for, Age Related Macular Degeneration, Dry Eye Syndrome and Meibomian Gland Dysfunction. The clinically supported ingredients in TOZAL aid in the treatment of inflammatory conditions of the eye.

Contraindications

TOZAL is contraindicated in patients with a known hypersensitivity to any of the ingredients in the formulation.

Warnings

Tamper Evident: For your protection, this bottle has an imprinted seal around the neck. Do Not Use if seal is damaged or missing at time of purchase.

Precautions

Consult your doctor before taking TOZAL with other supplements.

Pregnancy:

Category C: There are no adequate and well-controlled studies inpregnant women. TOZAL should be used during pregnacy only if the potential benefit justifies the potential risk.

Pediatric Use:

There are no adequate and well-controlled studies for pediatric use.

Adverse Reactions/Side Effects

No serious side effects have been experienced with the consumption of normal amounts of these ingredients.

Tozal Dosage and Administration

Take three softgels daily. TOZAL should be taken with food.

How is Tozal supplied

TOZAL softgels are packed in a 90 count bottle (15821-501-90).

Storage and Handling

Store at controlled room temperature 15 - 30 C (59-86 F). Keep container tightly closed. See bottle or foil sample pouch for Lot Number and Expiration Date.

Product Label

TOZAL
softgel capsule, gelatin coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:15821-501
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A10000 [iU] in 3
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID452 mg in 3
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL1000 [iU] in 3
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL200 [iU] in 3
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE20 mg in 3
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg in 3
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN100 ug in 3
ZINC PICOLINATE (UNII: ALO92O31SE) (ZINC CATION - UNII:13S1S8SF37) ZINC PICOLINATE40 mg in 3
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER1.6 mg in 3
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) OMEGA-3 FATTY ACIDS600 mg in 3
TAURINE (UNII: 1EQV5MLY3D) (TAURINE - UNII:1EQV5MLY3D) TAURINE400 mg in 3
LUTEIN (UNII: X72A60C9MT) (LUTEIN - UNII:X72A60C9MT) LUTEIN15 mg in 3
ZEAXANTHIN (UNII: CV0IB81ORO) (ZEAXANTHIN - UNII:CV0IB81ORO) ZEAXANTHIN3 mg in 3
Product Characteristics
ColororangeScoreno score
ShapeOVALSize16mm
FlavorFISHImprint CodeTOZAL
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15821-501-9090 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/2013
Labeler - FOCUS Laboratories, Inc. (926378337)
Establishment
NameAddressID/FEIBusiness Operations
Best Formulations147341796analysis(15821-501) , manufacture(15821-501)
Establishment
NameAddressID/FEIBusiness Operations
Future Pak087737672label(15821-501) , pack(15821-501)