Label: NESTABS DHA PRENATAL MULTI-VITAMIN/MINERAL SUPPLEMENT WITH DHA/EPA (sodium ascorbate, cholecalciferol, di-alpha-tocopheryl acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hcl, folic acid, cyanocobalamin, calcium formate, calcium carbonate, ferrous- ii bis-glycinate chelate, potassium iodide, zinc oxide, choline bitartrate, with doconexent and icosapent kit

  • NDC Code(s): 50967-317-30
  • Packager: WOMENS CHOICE PHARMACEUTICALS LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 18, 2023

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  • DESCRIPTION

    D escripton:   Nestabs DHA combination tablet-capsule for oral administration is a light pink capsule-shaped film coated tablet with a pleasant sweet flavor with WCOO1 imprinted on one side of the tablet and a enteric coated light amber soft gel capsule omega-3 fatty acid containing both DHA and EPA.

  • INDICATIONS & USAGE

    I ndications and Usage: Nestabs DHA is indicated to provide vitamin/mineral and omega-3 fatty acid supplementation to women throughout pregnancy, during the postnatal for both lactating and nonlactating mothers. Nestabs DHA is also beneficial in improving the nutritional status of women prior to conception.

  • CONTRAINDICATIONS

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

  • WARNINGS

    W arnings: Ingestion of more than 3 grams of omega-fatty acids per day has been shown to have potential antithrombotic effects, including increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

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


  • 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.

  • PRECAUTIONS

    P recautions:  Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. This product contains formate, which if consumed above the recommended level, could cause visual impairment and other health effects. Do not take more than the recommended amount. If you are pregnant, nursing, or taking any medications consult your doctor before use. Discontinue use and consult your doctor if any adverse reactions occur. Not intended for use by persons under the age of 18.

  • ADVERSE REACTIONS

    A dverse Reactions:  Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

  • DOSAGE & ADMINISTRATION

    D osage and Administration: Nestabs DHA - One tablet and one soft gel capsule daily or as directed by a physician.

  • HOW SUPPLIED

    H ow Supplied:  Nestabs DHA tablets for oral administration are supplied as six child-resistant blister cards containing 5 tablets and 5 softgel capsules each (NDC# 50967-317-30).

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    NESTABS DHA  PRENATAL MULTI-VITAMIN/MINERAL SUPPLEMENT WITH DHA/EPA
    sodium ascorbate, cholecalciferol, di-alpha-tocopheryl acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hcl, folic acid, cyanocobalamin, calcium formate, calcium carbonate, ferrous (ii) bis-glycinate chelate, potassium iodide, zinc oxide, choline bitartrate, with doconexent and icosapent kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50967-317
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50967-317-304 in 1 CARTON02/01/2011
    11 in 1 BLISTER PACK
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1 30 
    Part 2 30 
    Part 1 of 2
    NESTABS  MULTI-VITAMIN/MINERAL SUPPLEMENT
    sodium ascorbate, cholecalciferol, di-alpha-tocopheryl acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hcl, folic acid, cyanocobalamin, calcium formate, calcium carbonate, ferrous (ii) bis-glycinate chelate, potassium iodide, zinc oxide, choline bitartrate tablet
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE ION3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE50 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN10 ug
    CALCIUM FORMATE (UNII: NP3JD65NPY) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION155 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION45 mg
    FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION32 mg
    SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL450 [iU]
    ALPHA-TOCOPHERYLQUINONE (UNII: ZO763K43XR) (ALPHA-TOCOPHERYLQUINONE - UNII:ZO763K43XR) ALPHA-TOCOPHERYLQUINONE30 [iU]
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION100 ug
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 mg
    CHOLINE BITARTRATE (UNII: 6K2W7T9V6Y) (CHOLINE - UNII:N91BDP6H0X) CHOLINE55 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE (UNII: FZ989GH94E)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SACCHARIN (UNII: FST467XS7D)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code WC;001
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2011
    Part 2 of 2
    NESTABS OMEGA 3-DHA 
    doconexent and icosapent supplement capsule, gelatin coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT230 mg
    ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT30 mg
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-2 [iU]
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize6mm
    FlavorImprint Code ;
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2011
    Labeler - WOMENS CHOICE PHARMACEUTICALS LLC (833067841)
    Registrant - WOMENS CHOICE PHARMACEUTICALS LLC (833067841)
    Establishment
    NameAddressID/FEIBusiness Operations
    Women's Choice Pharmaceuticals833067841label(50967-317)