Label: TOBAKIENT- ascorbic acid, cholecalciferol, riboflavin, pyridoxine hcl, folic acid, l-glutathione, astaxanthin capsule

  • NDC Code(s): 71905-100-30
  • Packager: Levins Pharmaceuticals, LLC
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated February 20, 2019

If you are a consumer or patient please visit this version.

  • STATEMENT OF IDENTITY

    Tobakient™ Capsules Dietary Supplement

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  • Health Claim

    Dispensed by Prescription†

    Tobakient™ is an orally administered prescription vitamin formulation for the clinical dietary management of suboptimal nutritional status in patients experiencing physiologically stressful conditions such as use of tobacco products, or to maintain levels when dietary intake of vitamins is inadequate or excretion or loss is excessive. ††

    †This product is a prescription- folic acid with or without other dietary ingredients that – due to increased folic acid levels increased risk associated with masking of B12
    deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (61 FR 8760). 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)

    †† These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

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  • WARNINGS

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

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  • PRECAUTIONS

    Tobakient™ capsules 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.

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  • DOSAGE & ADMINISTRATION

    Usual adult dose is one (1) capsule once or twice daily or as prescribed by a licensed medical practitioner.

    Tobakient™ capsules are supplied as (blue and white, oblong-shaped) capsules in a child-resistant bottle of 30-count ("71905-0100-30"**).

    **Levins Pharmaceuticals 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.

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  • SAFE HANDLING WARNING

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

    KEEP OUT OF REACH OF CHILDREN

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

    To report adverse events or to obtain product information, contact 228-392-0043.

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  • INGREDIENTS AND APPEARANCE
    TOBAKIENT 
    ascorbic acid, cholecalciferol, riboflavin, pyridoxine hcl, folic acid, l-glutathione, astaxanthin capsule
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:71905-100
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 1.7 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 200 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 2 mg
    GLUTATHIONE (UNII: GAN16C9B8O) (GLUTATHIONE - UNII:GAN16C9B8O) GLUTATHIONE 250 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 20 ug
    ASTAXANTHIN (UNII: 8XPW32PR7I) (ASTAXANTHIN - UNII:8XPW32PR7I) ASTAXANTHIN 4 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1667 ug
    Inactive Ingredients
    Ingredient Name Strength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    GELATIN (UNII: 2G86QN327L)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:71905-100-30 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    dietary supplement 03/04/2019
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving % Daily Value
    size (solid drugs) 21 mm
    scoring 1
    color
    color
    shape
    Labeler - Levins Pharmaceuticals, LLC (080839485)
    Registrant - Levins Pharmaceuticals, LLC (080839485)
    Establishment
    Name Address ID/FEI Business Operations
    FORMULIFE, INC. 024442806
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