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NataFort (Mission Pharmacal Company)

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TABLET 90 TABLET in 1 BOTTLE (0178-0716-90) Label Information

Complete NataFort Information

  • BOXED WARNING(What is this?)

    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 case of accidental overdose, call a doctor or poison control center immediately.


  • DESCRIPTION

    NataFort® is a prescription prenatal/postnatal multivitamin/mineral supplement. The tablet is white, coated, and oval in shape, and is debossed "N1" on one side and is blank on the other.

    Each prenatal tablet contains:
    Vitamin C (Ascorbic acid) 120 mg
    Vitamin D3 (Cholecalciferol) 400 IU
    Vitamin E (dl-alpha tocoperyl acetate)   11 IU
    Thiamin (Vitamin B1)     2 mg
    Riboflavin (Vitamin B2)     3 mg
    Niacinamide (Vitamin B3)   20 mg
    Vitamin B6 (Pyridoxine HCl)   10 mg
    Folic Acid     1 mg
    Vitamin B12 (Cyanocobalamin)   12 mcg
    Iron (Ferrous fumarate, carbonyl iron)   60 mg

  • INDICATIONS

    NataFort® is a multivitamin/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.


  • WARNING

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 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 as directed by a physician.


  • STORAGE AND HANDLING

    Store at controlled room temperature.

    NOTICE: Contact with moisture can discolor or erode the tablet.


  • HOW SUPPLIED

    Bottles of 90 tablets each - NDC 0178-0716-90.


  • SPL UNCLASSIFIED SECTION

    US Patent 6,521,247

    MISSION PHARMACAL COMPANY
    San Antonio, TX USA 78230 1355

    Copyright © 2011 Mission Pharmacal Company.

    All rights reserved.

    L071690 C01 Rev 005110


  • PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

    NDC 0178-0716-90

    NataFort®
    PRENATAL MULTIVITAMIN TABLET WITH IRON
    For use before, during and after pregnancy

    90 Tablets

    Rx Only

    Mission®
    PHARMACAL

    US Patent 6,521,247

    PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

  • INGREDIENTS AND APPEARANCE
    NATAFORT 
    ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, and iron tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0178-0716
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Ascorbic acid (UNII: PQ6CK8PD0R) (Ascorbic acid - UNII:PQ6CK8PD0R) Ascorbic acid 120 mg
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol 400 [iU]
    .alpha.-tocopherol acetate, dl- (UNII: WR1WPI7EW8) (.alpha.-tocopherol acetate, dl- - UNII:WR1WPI7EW8) .alpha.-tocopherol acetate, dl- 11 [iU]
    Thiamine mononitrate (UNII: 8K0I04919X) (Thiamine - UNII:X66NSO3N35) Thiamine mononitrate 2 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 3 mg
    Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide 20 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 10 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1 mg
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 12 ug
    Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron 60 mg
    Inactive Ingredients
    Ingredient Name Strength
    polyethylene glycols (UNII: 3WJQ0SDW1A)  
    calcium carbonate (UNII: H0G9379FGK)  
    povidone (UNII: FZ989GH94E)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    croscarmellose sodium (UNII: M28OL1HH48)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    magnesium silicate (UNII: 9B9691B2N9)  
    vitamin a palmitate (UNII: 1D1K0N0VVC)  
    magnesium stearate (UNII: 70097M6I30)  
    ethyl vanillin (UNII: YC9ST449YJ)  
    Dimethylaminoethyl methacrylate - butyl methacrylate - methyl methacrylate copolymer (UNII: 905HNO1SIH)  
    Product Characteristics
    Color WHITE Score no score
    Shape OVAL Size 14mm
    Flavor Imprint Code N1
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0178-0716-90 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 08/25/2011
    Labeler - Mission Pharmacal Company (008117095)
    Establishment
    Name Address ID/FEI Business Operations
    Mission Pharmacal Company 927726893 MANUFACTURE