Label: NATAFORT- ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, and iron tablet

  • NDC Code(s): 0178-0716-90
  • Packager: Mission Pharmacal Company
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 10, 2011

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

  • 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.

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  • 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
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  • 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.

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  • CONTRAINDICATIONS

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

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  • WARNING

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

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  • PRECAUTIONS

    Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

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  • ADVERSE REACTIONS

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

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  • DOSAGE AND ADMINISTRATION

    One tablet daily or as directed by a physician.

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  • STORAGE AND HANDLING

    Store at controlled room temperature.

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

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  • HOW SUPPLIED

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

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  • 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

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  • 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
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  • 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
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