Label: PRENATVITE tablet

  • NHRIC Code(s): 73317-1050-9
  • Packager: SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated February 5, 2020

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

  • DESCRIPTION

    SUPPLEMENT FACTS:

    Serving Size: One Tablet

    PRENATVITE RX is an orally administered prenatal dietary Supplement and should be administered under the supervision of a licensed medical practitioner.

    Each PRENATVITE tablet contains:

    VITAMIN A (AS ACETATE, BETA CAROTENE)

    1200 MCG

    VITAMIN C (ASCORBIC ACID)

    120 MG

    VITAMIN D3 (AS CHOLECALCIFEROL)

    10 MCG

    VITAMIN E (AS DL-ALPHA TOCOPHEROL ACETATE)

    4.6 MG

    VITAMIN B1 (AS THIAMINE MONONITRATE)

    1.5 MG
    VITAMIN B2 (AS RIBOFLAVIN)

    1.7 MG

    VITAMIN B3 (AS NIACINAMIDE)

    18 MG

    VITAMIN B6 (AS PYRIDOXINE HCL)

    2.6 MG

    FOLIC ACID

    800 MCG

    VITAMIN B12 (AS CYANOCOBALAMIN)

    4 MCG

    CALCIUM (AS CALCIUM CARBONATE & SULFATE)

    263 MG

    IRON (AS FERROUS FUMARATE)

    27 MG

    ZINC (AS ZINC OXIDE)

    25 MG

    INOSITOL

    5 MG

    CITRUS BIOFLAVONOIDS COMPLEX 50%

    2 MG

    BORON (AS BORON CITRATE)

    0.2 MG

    Other Ingredients:

    MICRO CRYSTALLINE CELLULOSE, DI CALCIUM PHOSPHATE, STEARIC ACID, CROSCARMELLOSE SODIUM, SILICON DIOXIDE, MAGNESIUM STEARATE, HPMC E15, HPMC E5/E6, PEG - 8000, TALC, FD&C RED # 40 (LAKE), FD&C YELLOW # 6 (LAKE), TRIACETIN.

    INDICATIONS
    PRENATVITE RX is a multi-vitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

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

  • WARNINGS

    WARNINGS

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

    CAUTION: High levels of folic acid may, especially in older adults, hide signs of Vitamin B-12 deficiency (such as pernicious anemia), a condition that can cause nerve damage.

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is deficient.
    PRECAUTIONS
    Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
    ADVERSE REACTIONS
    Allergic sensitization has been reported following both oral and parenteral administration of folic acid
    DOSAGE AND ADMINISTRATION

    One tablet daily or Take exactly as prescribed by your doctor. Take PRENATVITE RX tablet each day at any time of day at about the same time each day. PRENATVITE RX can be taken with or without food.
    STORAGE
    Store at 20-25°C (68-77°F) [See USP controlled room temperature].
    Do not keep medicine that is out of date or that you no longer need.
    Keep PRENATVITE RX Tablets and all medicines out of the reach of children.
    NOTICE
    Contact with moisture can discolor or erode the tablet.

  • HEALTH CLAIM

    HOW SUPPLIED

    Bottles of 90 tablets each - NDC 73317-1050-9


    To report a serious adverse event or obtain product information, call 631-524-5758


    Call your licensed medical practitioner about side effect.

    You may report side effects by calling AUM 1-631-524-5758.

    Manufactured and Distributed by:

    AUM Pharmaceuticals
    Hauppauge, NY 11788.

    Made in USA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PRENATVITE 
    prenatvite tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:73317-1050
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A1200 ug
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE4.6 mg
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.5 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.7 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE18 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE2.6 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID800 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN4 ug
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
    INOSITOL (UNII: 4L6452S749) (INOSITOL - UNII:4L6452S749) INOSITOL5 mg
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50) (HESPERIDIN - UNII:E750O06Y6O) CITRUS BIOFLAVONOIDS2 mg
    CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP) CALCIUM263 mg
    BORON (UNII: N9E3X5056Q) (BORON - UNII:N9E3X5056Q) BORON0.2 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TRIACETIN (UNII: XHX3C3X673)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:73317-1050-990 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT02/03/2020
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)5 mm
    Labeler - SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS (081225162)
    Establishment
    NameAddressID/FEIBusiness Operations
    SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS081225162repack(73317-1050)