DYZBAC- ubidecarenone, alpha lipoic acid, resveratrol, leucovorin, pyridoxal 5-phosphate, methylcobalamin, ascorbic acid and cholecalciferol tablet 
Basiem

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.

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Dyzbac

DESCRIPTION:

Dyzbac Tablets is an oral prescription (Rx) dietary supplement for the dietary management of patients with unique nutritional needs where advanced folate supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.


Each Tablet Contains:

  • Resveranoic*                 225 mg
  • Folinic Acid                         1 mg
  • Pyridoxal 5’ Phosphate    12.5 mg
  • Methylcobalamin                 1 mg
  • Ascorbic Acid                  125 mg
  • Cholecalciferol                500  IU

*Resveranoic is a proprietary metabolic blend consisting of Ubidecarenone, Thiotic Acid, and Resveratrol.
Other Ingredients: microcrystalline cellulose, magnesium stearate, stearic acid, and silicon dioxide.

INDICATION AND USAGE

Dyzbac tablets is indicated for the dietary management of patients with unique nutritional needs requiring advanced folate supplementation and other nutritional supplementation in physiologically stressful conditions for maintenance of good health.

CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNINGS AND PRECAUTIONS

Dyzbac tablets should only be used under the direction and supervision of a licensed medical practitioner.

Use with caution in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking medications.

Dyzbac Tablets should be avoided in children.

Use with caution in patients who have a blood disorder, or are taking blood thinning medications such as aspirin, warfarin, or clopidrogrel.


Pregnancy And Lactation
Dyzbac is not intended for use in pregnant or lactating patients..

ADVERSE REACTIONS

You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact Basiem, LLC, Madisonville, LA 70477 at 1-844-551-9911.

DOSAGE AND ADMINISTRATION

Usual adult dose is 1-2 tablets twice daily or as prescribed by a licensed medical practitioner.

HOW SUPPLIED

Dyzbac tablets are supplied as red, oblong shaped tablets with imprint “312” in a child-resistant bottle of 30ct. (NDC 69597-312-30).

STORAGE AND HANDLING

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.]
Protect from heat, light and moisture.

KEEP OUT OF THE REACH OF CHILDREN.

Tamper Evident: Do not use if seal is broken or missing

PACKAGE LABEL

image description

DYZBAC 
resveranoic, folinic acid, pyridoxal 5 phosphate, methylcobalamin, ascorbic acid, cholecalciferol tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69597-313
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46) UBIDECARENONE25 mg
ALPHA LIPOIC ACID (UNII: 73Y7P0K73Y) (ALPHA LIPOIC ACID - UNII:73Y7P0K73Y) ALPHA LIPOIC ACID150 mg
RESVERATROL (UNII: Q369O8926L) (RESVERATROL - UNII:Q369O8926L) RESVERATROL50 mg
LEUCOVORIN (UNII: Q573I9DVLP) (LEUCOVORIN - UNII:Q573I9DVLP) LEUCOVORIN1 mg
PYRIDOXAL 5-PHOSPHATE (UNII: F06SGE49M6) (PYRIDOXAL 5-PHOSPHATE - UNII:F06SGE49M6) PYRIDOXAL 5-PHOSPHATE12.5 mg
METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN1 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID125 mg
Cholecalciferol (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) Cholecalciferol500 [iU]
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize16mm
FlavorImprint Code 312
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69597-313-3030 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/05/201501/01/2016
Labeler - Basiem (079686680)
Establishment
NameAddressID/FEIBusiness Operations
Basiem079686680label(69597-313)

Revised: 1/2016
 
Basiem