Label: MEBOLIC- ascorbic acid, cholecalciterol, thiamin hcl, pyridoxal 5 phosphate, folic acid, methylcobalamin, adenine dinucleotide, ubiquinone tablet

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated October 10, 2019

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  • HEALTH CLAIM:

    Mebolic Tablets Dietary Supplement

    Dispensed by Prescription

    Supplement Facts
    Serving Size: 1 Tablet

    Servings per Bottle: 30

    Amount Per Serving: % Daily Value
     Vitamin C (as ascorbic acid)   125 mg  208%
     Vitamin D3 (as cholecalciferol)   500 IU  125%
     Thiamin (Vitamin B1 as thiamin HCl)  25 mg  1,667%
     Vitamin B6 (as pyridoxal 5’ phosphate)  12.5 mg  625%
     Folic Acid   1 mg  250%
     Vitamin B12 (as methylcobalamin)  1 mg  16,667%
     NADH (reduced nicotinamide-adenine dinucleotide)  5 mg *
     CoEnzyme Q-10 (ubiquinone)   50 mg *
    *Daily Values (DV) not established.

    OTHER INGREDIENTS:  cellulose, magnesium stearate, and silicon dioxide.

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  • DESCRIPTION:

    Mebolic Tablets is an orally administered prescription vitamin formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced folate supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.

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  • WARNING AND PRECAUTIONS

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

    Mebolic 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.


    Pregnancy and Lactation
    Mebolic is not intended for use in pregnant or lactating patients.

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  • DOSAGE & ADMINISTRATION

    Usual adult dose is 1 tablet once or twice daily or as prescribed by a licensed medical practitioner.

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  • HOW SUPPLIED HEALTH CLAIM:

    Mebolic tablets are supplied as tan, oblong shaped tablets with imprint “314”in a child-resistant bottle of 30ct. (69499-314-30*)

    Dispensed by Prescription

    *Solubiomix does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.

    † This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking of B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760).1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription (Rx).  This is not an Orange Book product. This product may be administered only under a physician’s supervision and all prescriptions using this product shall be pursuant to state statutes as applicable.  The ingredients, indication or claims of this product are not to be construed to be drug claims.

    1. Federal Register Notice of August 2, 1973 (38 FR 20750)
    2. Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)
    3. Federal Register Notice of March 5, 1996 (61 FR 8760)
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  • 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.

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  • PACKAGE LABEL:
  • INGREDIENTS AND APPEARANCE
    MEBOLIC 
    ascorbic acid, cholecalciterol, thiamin hcl, pyridoxal 5 phosphate, folic acid, methylcobalamin, adenine dinucleotide, ubiquinone tablet
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:69499-314
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 125 mg
    cholecalciferol (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) cholecalciferol 500 [iU]
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE 25 mg
    PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6) PYRIDOXAL PHOSPHATE ANHYDROUS 12.5 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN 1 mg
    NADH (UNII: 4J24DQ0916) (NADH - UNII:4J24DQ0916) NADH 5 mg
    COENZYME Q10, (2Z)- (UNII: U705VLF0VW) (COENZYME Q10, (2Z)- - UNII:U705VLF0VW) COENZYME Q10, (2Z)- 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    .BETA.-CAROTENE (UNII: 01YAE03M7J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:69499-314-30 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    dietary supplement 07/18/2016 10/31/2019
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving % Daily Value
    color
    shape
    imprint
    size (solid drugs) 19 mm
    scoring 1
    Labeler - Solubiomix (079640556)
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