Label: GENICIN VITA-S- vitamin c, thiamine, riboflavin, niacin, vitamin b6, folate, vitamin b12, biotin, panothenic acid tablet

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

Drug Label Information

Updated October 17, 2018

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

  • DOSAGE & ADMINISTRATION

    RECOMMENDED DOSAGE: 
    Usual adult dose is 1 tablet once or twice daily or as prescribed by a licensed medical practitioner. If you are pregnant or nursing, ask a healthcare professional.

    Genicin Vita-S contains the following inactive ingredients: Microcrystalline Cellulose, Dicalcium Phosphate, Stearic Acid, Croacarmellose Sodium, and Magnesium Stearate.

  • Genicin Vita-S

    is an orally administered prescription vitamin formulation used for the clinical dietary management of suboptimal nutritional status in patients where advanced folate supplementation is required and other nutritional supplementation is needed.

  • WARNINGS:

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

    Genicin Vita-S 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.

  • PRECAUTIONS:

    KEEP OUT OF REACH OF CHILDREN.

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

    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 

    Genicin Vita-S is not intended for use in pregnant or lactating patients.

    Genicin Vita-S is supplied in:
    30ct bottles (70645-403-30*)
    Dispensed by Prescription†

  • Dietary Supplement

    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.

    * 7T Pharma 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)

    Genicin Vita-S Tablets

    Manufactured for:
    7T Pharma, LLC
    Los Angeles, CA 90064
    800.941.2848

  • PRINCIPAL DISPLAY PANEL

    NDC 70645-403-30
    Genicin Vita-S
    30 Tablets

    PRINCIPAL DISPLAY PANEL
NDC 70645-403-30
Genicin Vita-S
30 Tablets

  • INGREDIENTS AND APPEARANCE
    GENICIN VITA-S 
    vitamin c, thiamine, riboflavin, niacin, vitamin b6, folate, vitamin b12, biotin, panothenic acid tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:70645-403
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.5 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.7 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE10 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1000 ug
    METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN6 ug
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN300 ug
    PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID10 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:70645-403-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT10/01/2018
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)5 mm
    Labeler - 7T Pharma LLC (080220022)