Dyzbac tablet

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

Dyzbactablets 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

Dyzbactablets 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 20-25C (68-77F); excursions permitted to 15-30C (59-86F) [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

Ingredients and appearance - Product information

Dyzbac tablet- Resveranoic, folinic acid, pyridoxal 5 phosphate, methylcobalamin, ascorbic acid, cholecalciferol

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 69597-313
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Ubidecarenone ( UNII: EJ27X76M46)( Ubidecarenone - UNII: EJ27X76M46 ) 25 mgin 1
Alpha lipoic acid ( UNII: 73Y7P0K73Y)( Alpha lipoic acid - UNII: 73Y7P0K73Y ) 150 mgin 1
Resveratrol ( UNII: Q369O8926L)( Resveratrol - UNII: Q369O8926L ) 50 mgin 1
Leucovorin ( UNII: Q573I9DVLP)( Leucovorin - UNII: Q573I9DVLP ) 1 mgin 1
Pyridoxal 5-phosphate ( UNII: F06SGE49M6)( Pyridoxal 5-phosphate - UNII: F06SGE49M6 ) 12.5 mgin 1
Methylcobalamin ( UNII: BR1SN1JS2W)( Methylcobalamin - UNII: BR1SN1JS2W ) 1 mgin 1
Ascorbic acid ( UNII: PQ6CK8PD0R)( Ascorbic acid - UNII: PQ6CK8PD0R ) 125 mgin 1
Cholecalciferol ( UNII: 1C6V77QF41)( Cholecalciferol - UNII: 1C6V77QF41 ) 500 [iU]in 1

Inactive Ingredients

Ingredient Name Code
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Magnesium stearate ( UNII: 70097M6I30)
Stearic acid ( UNII: 4ELV7Z65AP)
Silicon dioxide ( UNII: ETJ7Z6XBU4)

Product Characteristics

Color red Shape OVAL
Size 16 mm Score 1
Imprint Code 312

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved drug other USA

Labeler - Basiem( 079686680)

Establishment

Name ID/FEI Business Operations
Basiem 079686680 label( 69597-313)

Package label