Label: NESTABS ONE- vitamin c, vitamin d, vitamin e, vitamin b6, folate, vitamin b12, iron, zinc, magnesium, dha capsule, gelatin coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated April 15, 2022

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  • DESCRIPTION

    DESCRIPTION: Nestabs® One is a prescription prenatal multi-vitamin/mineral in the form of a purple, opaque softgel capsule imprinted “ONE” for oral administration.

  • DOSAGE FORMS & STRENGTHS

    Each NESTABS® ONE Softgel contains:
    Vitamin C (as calcium ascorbate) 18 mg
    Vitamin D (as cholecalciferol) 6.25 mcg
    Vitamin E (as d-alpha tocopheryl acetate) 10 mg
    Vitamin B6 (as pyridoxine HCl) 30 mg
    Folate (as (6S)-5 1 mg DFE*
    -methyltetrahydrofolate -Quatrefolic®) ‡
    Vitamin B12 (as cyanocobalamin) 15 mcg
    Iron (as carbonyl iron and ferrous 38 mg
    bis-glycinate chelate -Ferrochel®) ‡‡
    Zinc (as zinc oxide) 20 mg
    Magnesium (as magnesium oxide) 15 mg
    DHA (Docosahexaenoic Acid from Algal Oil) 225 mg
    *Dietary Folate Equivalent (DFE)

  • INACTIVE INGREDIENT


    Other Ingredients: Gelatin capsule (bovine gelatin, glycerin, purified water, titanium dioxide, FD&C Red #40, FD&C Blue #1), soy lecithin, docusate sodium, white beeswax.
    Contains Soy.

  • INDICATIONS & USAGE

    INDICATION AND USAGE: Nestabs® One is a prescription prenatal multi-vitamin/mineral supplement with DHA that can be taken throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers.
    Nestabs® One may also be useful in improving the nutritional status of women prior to conception. The usual dose is one softgel daily, or as directed by a physician.

  • CONTRAINDICATIONS

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

  • BOXED WARNING (What is this?)

    WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately

  • WARNINGS

    WARNINGS: Ingestion of more than 3 grams of omega-3 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.

  • PRECAUTIONS

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

  • ADVERSE REACTIONS

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

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: One softgel taken orally each day, or as directed by a physician.

  • STORAGE AND HANDLING

    STORAGE: Store between 15-30°C (59°-86°F). Protect from extreme temperatures. Freezing & excessive heat may damage softgels.

  • HOW SUPPLIED

    HOW SUPPLIED: Nestabs® One softgels for oral
    administration are supplied in child resistant bottles
    containing 30 softgels, Item 50967-410-30 and as
    professional samples, Item 50967-410-03.


    Rx


    To report a serious adverse event or obtain product information, contact 1-800-664-1490.


    Distributed By:
    Womens Choice Pharmaceuticals, LLC
    Berwyn, PA 19312
    www.wcpharma.com


    Nestabs® is a registered trademark of
    Womens Choice Pharmaceuticals, LLC
    ‡ Quatrefolic® under exclusive license from
    Gnosis, S.p.A covered by U.S. Patent No. 7,947,662
    and patents pending PCT/EP2008/052037
    and PCT/EP2008/052034
    ‡‡ Ferrochel® is a registered trademark of
    Albion Laboratories, Inc., covered by
    U.S. Patents 6,716,814 and 7,838,042.

  • PRINCIPAL DISPLAY PANEL

    label

  • PRINCIPAL DISPLAY PANEL

    PI

  • INGREDIENTS AND APPEARANCE
    NESTABS ONE 
    vitamin c, vitamin d, vitamin e, vitamin b6, folate, vitamin b12, iron, zinc, magnesium, dha capsule, gelatin coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50967-410
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON38 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    ANTAZOLINE (UNII: DHA8014SS1) (ANTAZOLINE - UNII:DHA8014SS1) ANTAZOLINE225 mg
    TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL10 mg
    CALCIUM ASCORBATE (UNII: 183E4W213W) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID18 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN15 ug
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION15 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL6.25 ug
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN TYPE B BOVINE (160 BLOOM) (UNII: 1T8387508X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Colorpurple (Opaque) Scoreno score
    ShapeOVALSize18mm
    FlavorImprint Code ONE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50967-410-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/20/2017
    Labeler - Womens Choice Pharmaceuticals, LLC (833067841)