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Tozal

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

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Tozal

15821-501-90
Tozal
Complete Eye Health Formula

Actilease

for better absorption

Actilease

for better absorption

Dispense by Prescription

Medical Food

90 Softgels

Tozal         GLUTEN FEE

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:

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:

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

DOSAGE AND ADMINISTRATION:

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

HOW SUPPLIED:

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

Storage:

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.

Tozal 
softgel capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:15821-501
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A PALMITATE (VITAMIN A) VITAMIN A 10000 [iU]  in 3 
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 452 mg  in 3 
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 1000 [iU]  in 3 
ALPHA-TOCOPHEROL (.ALPHA.-TOCOPHEROL) ALPHA-TOCOPHEROL 200 [iU]  in 3 
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 20 mg  in 3 
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg  in 3 
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 100 ug  in 3 
ZINC PICOLINATE (ZINC CATION) ZINC PICOLINATE 40 mg  in 3 
COPPER (COPPER) COPPER 1.6 mg  in 3 
OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS) OMEGA-3 FATTY ACIDS 600 mg  in 3 
TAURINE (TAURINE) TAURINE 400 mg  in 3 
LUTEIN (LUTEIN) LUTEIN 15 mg  in 3 
ZEAXANTHIN (ZEAXANTHIN) ZEAXANTHIN 3 mg  in 3 
Product Characteristics
Color orange Score no score
Shape OVAL Size 16mm
Flavor FISH Imprint Code Tozal
Contains         
Packaging
# Item Code Package Description
1 NDC:15821-501-90 90 CAPSULE, GELATIN COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/01/2013
Labeler - FOCUS Laboratories, Inc. (926378337)
Establishment
Name Address ID/FEI Operations
Best Formulations 147341796 analysis(15821-501), manufacture(15821-501)
Establishment
Name Address ID/FEI Operations
Future Pak 087737672 label(15821-501), pack(15821-501)
Revised: 04/2014
 
FOCUS Laboratories, Inc.



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