Label: VITALARA- beta carotene, ascorbic acid, cholecalciferol, dl-alpha-tocopheryl acetate, pyridoxine hydrochloride, folic acid, 5-methyl tetrahydrofolate, calcium salt, cyanocobalamin, biotin, calcium carbonate, ferrous bisglycinate, potassium iodine, magnesium oxide tablet

  • NDC Code(s): 86001089074
  • Packager: Aletris Pharmaceuticals, LLC
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated December 6, 2024

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  • HEALTH CLAIM

    VITALARA-Dispensed by Prescription

  • STATEMENT OF IDENTITY

    VITALARA- beta carotene, ascorbic acid, cholecalciferol, dl-alpha-tocopheryl acetate, pyridoxine hydrochloride, folic acid, 5-methyl tetrahydrofolate, calcium salt, cyanocobalamin, biotin, calcium carbonate, ferrous bisglycinate, potassium iodine, and magnesium oxide tablet.

    Serving Size: 1 Tablet

    Servings Per Container: 30

    Each Tablet Contains:

    %DV

    Vitamin A (as Beta-Carotene)                     

    300 mcg RAE 

    23%

    Vitamin C (as ascorbic acid) 

    60 mg

    50%

    Vitamin D3 (as cholecalciferol)

    10 mcg

    67%

    Vitamin E (as dl-Alpha-Tocopheryl Acetate)

    45 mg

    24%

    Vitamin B6 (as pyridoxine HCl)

    26 mg

    1300%

    Folate

    (From Folic Acid)

    (From 5-Methyl Tetrahydrofolate, Calcium Salt)

    1670 mcg DFE

    278%

     Vitamin B12 (as Cyanocobalamine)

    13 mcg

    464%

    Biotin

    28 mg

    80%

    Calcium (from Calcium Carbonate) 

    80 mg

    6%

    FerrochelTM Iron (as ferrous BisGlycinate Chelate)

    12 mg

    44%

    Iodine (as potassium iodide)

    150 mcg

    52%

    Magnesium (as Magnesium oxide)

    25 mg

    6%

    * -Percent Daily Value for pregnant and/or lactating women

    OTHER INGREDIENTS: Modified Cellulose, Stearic Acid, Croscarmellose Sodium, Silicon Dioxide, Magnesium Stearate, Polyethylene Glycol, Polydextrose, Titanium Dioxide, FD&C #1 Blue Lake

    Allergen: NONE

  • DESCRIPTION

    VITALARA is a prescription prenatal/postnatal multivitamin/ multimineral dietary supplement.

  • INDICATIONS

    VITALARA is a multivitamin/multimineral dietary supplement indicated for the use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers.

  • CONTRADINDICATIONS

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

  • WARNING

    Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In the case of accidental overdose, call a doctor or poison control center immediately.

  • ADVERSE REACTIONS

    Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

    You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact: Aletris Pharmaceuticals, LLC at 228-207-8112.

  • DOSAGE AND ADMINISTRATION

    Before, during and/or after pregnancy, one tablet daily with food or as directed by a physician.

  • PRECAUTION:

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

  • STORAGE

    Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Avoid excessive heat, light
    and moisture.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    VITALARA 
    beta carotene, ascorbic acid, cholecalciferol, dl-alpha-tocopheryl acetate, pyridoxine hydrochloride, folic acid, 5-methyl tetrahydrofolate, calcium salt, cyanocobalamin, biotin, calcium carbonate, ferrous bisglycinate, potassium iodine, magnesium oxide tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)86001089074
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
    BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE300 ug
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-45 mg
    PYRIDOXINE HCL (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE26 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1670 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN13 ug
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN28 ug
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION80 mg
    FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION20 mg
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION150 ug
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION25 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18600108907430 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement12/06/2024
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    shape
    scoring1
    size (solid drugs)19 mm
    Labeler - Aletris Pharmaceuticals, LLC (118956541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aletris Pharmaceuticals, LLC118956541
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