Label: DEXIVITE- ascorbic acid, cholecalciferol, thiamine, pyridoxal-5-phosphate, folic acid, methylcobalamin, calcium carbonate, ferrous gluconate, iodine tablet

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

Drug Label Information

Updated November 9, 2019

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

  • HEALTH CLAIM:

    Dexivite Tablets - Prenatal/Postnatal Dietary Supplement

    Dispensed by Prescription

    Supplement Facts 
    Serving Size: 1 Tablet
    Serving per Bottle: 30
    Amount Per Serving:% Daily Value
    Vitamin C (as ascorbic acid)125 mg104%
    Vitamin D3 (as cholecalciferol)12.5 mcg (500 IU)83%
    Thiamine (Vitamin B1 as thiamine HCl)1.4 mg 100%
    Vitamin B6 (as pyridoxal-5-phosphate)2.5 mg125%
    Folic Acid1,666 DFE (1 mg folic acid)278%
    Vitamin B12 (as methylcobalamin)1,000 mcg35,714%
    Calcium (from calcium carbonate)200 mg15%
    Iron (as ferrous gluconate)13 mg48%
    Iodine (as potassium iodide)150 mcg52%

    OTHER INGREDIENTS: Microcrystalline Cellulose, Silicon Dioxide and Magnesium Stearate.

  • DESCRIPTION:

    Dexivite Tablets is a prescription dietary supplement for use throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Dexivite Tablets may be useful in improving the nutritional status of women prior to conception.

  • WARNING AND PRECAUTIONS

    WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

  • PRECAUTIONS

    CONTRAINDICATIONS:
    Dexivite Tablets are contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

    PRECAUTION:
    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Dexivite
    Tablets should only be used under the direction and supervision of a licensed medical practitioner.

    ADVERSE REACTIONS:
    Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You may report side effects by calling the FDA at 1-800-FDA-1088.

  • DOSAGE & ADMINISTRATION:

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

  • HOW SUPPLIED HEALTH CLAIM:

    Dexivite Tablets are available as white, round tablets and are available in 30-count bottles (72336-044-01*). This product is not an Orange Book product.

    Dispensed by Prescription†

    Manufactured for: Lifsa Drugs LLC, New Brunswick, NJ 08901

    Rev. 08/19

    * Lifsa Drugs LLC 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. 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)

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

    Distributed by: Lifsa Drugs LLC, New Brunswick, NJ 08901

  • Packaging

    Label

  • INGREDIENTS AND APPEARANCE
    DEXIVITE 
    ascorbic acid, cholecalciferol, thiamine, pyridoxal-5-phosphate, folic acid, methylcobalamin, calcium carbonate, ferrous gluconate, iodine tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:72336-044
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID125 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL0.0125 mg
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.4 mg
    PYRIDOXAL PHOSPHATE ANHYDROUS (UNII: F06SGE49M6) (PYRIDOXAL PHOSPHATE ANHYDROUS - UNII:F06SGE49M6) PYRIDOXAL PHOSPHATE ANHYDROUS2.5 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN1 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
    FERROUS GLUCONATE (UNII: U1B11I423Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION13 mg
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION0.15 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:72336-044-0130 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement11/01/2019
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    shape
    size (solid drugs)20 mm
    scoring1
    Labeler - Lifsa Drugs Llc (081205160)