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Generic Name: dietary supplement
Dosage Form: tablet

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.

DESCRIPTION:

Mebolex 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

Mebolex 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

Mebolex 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.

Mebolex 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
Mebolex 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 Solubiomix, LLC, Madisonville, LA 70477 at 1-844-551-9911.

Mebolex Dosage and Administration

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

How is Mebolex Supplied

Mebolex 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

Mebolex 
resveranoic, folinic acid, pyridoxal 5 phosphate, methylcobalamin, ascorbic acid, cholecalciferol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69499-312
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UBIDECARENONE (UBIDECARENONE) UBIDECARENONE 25 mg
ALPHA LIPOIC ACID (.ALPHA.-LIPOIC ACID, (+/-)-) ALPHA LIPOIC ACID 150 mg
RESVERATROL (RESVERATROL) RESVERATROL 50 mg
LEUCOVORIN (LEUCOVORIN) LEUCOVORIN 1 mg
PYRIDOXAL 5-PHOSPHATE (PYRIDOXAL 5-PHOSPHATE) PYRIDOXAL 5-PHOSPHATE 12.5 mg
METHYLCOBALAMIN (METHYLCOBALAMIN) METHYLCOBALAMIN 1 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 125 mg
Cholecalciferol (CHOLECALCIFEROL) Cholecalciferol 0.0125 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
MAGNESIUM STEARATE  
STEARIC ACID  
SILICON DIOXIDE  
Product Characteristics
Color red Score no score
Shape OVAL Size 16mm
Flavor Imprint Code 312
Contains         
Packaging
# Item Code Package Description
1 NDC:69499-312-30 30 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/28/2015
Labeler - Solubiomix (079640556)
Establishment
Name Address ID/FEI Operations
Solubiomix 079640556 label(69499-312)
Revised: 11/2015
 
Solubiomix
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