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Natelle One (Jazz Pharmaceuticals Commercial Corp.)

Available Formats

Dosage Form Package Information Links
CAPSULE, GELATIN COATED 3 CAPSULE, GELATIN COATED in 1 BLISTER PACK (18860-752-00) Label Information
CAPSULE, GELATIN COATED 30 CAPSULE, GELATIN COATED in 1 BOTTLE (18860-752-01) Label Information

Complete Natelle One Information

  • 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.


  • DESCRIPTION

    Natelle® One capsules for oral administration are supplied as oblong red soft gelatin capsules, imprinted with "Natelle1" in white ink.

    Each capsule contains:

    Docosahexaenoic Acid (DHA) .........................................................250 mg

    Eicosapentaenoic Acid (EPA)...............................Not more than 0.625mg

    Calcium (Tricalcium Phosphate).......................................................102 mg

    Iron (Ferrous Fumarate) ......................................................................28 mg

    Vitamin C (Ascorbic Acid) ...................................................................30 mg

    Vitamin B-6 (Pyridoxine HCl) ..............................................................25 mg

    Vitamin E (D-Alpha Tocopherol) ..........................................................30 IU

    Folic Acid .................................................................................................1 mg

    DHA is an omega-3 fatty acid. The DHA in Natelle® One is derived from Algal Oil (C.cohnii). 625 mg of Algal Oil is equivalent to 250 mg of DHA.

    Inactive Ingredients: Gelatin (Bovine), Beeswax, Glycerine, Soybean Oil, Lecithin, Titanium Dioxide, Ethyl Vanillin.


  • INDICATIONS AND USAGE

    Natelle® One is indicated to provide vitamin/mineral and DHA omega–3 fatty acid supplementation to women throughout pregnancy, during the postnatal period for both lactating and non–lactating mothers, and throughout the childbearing years. Natelle® One may be beneficial in improving the nutritional status of women prior to conception.


  • CONTRAINDICATIONS

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


  • 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.


  • PRECAUTIONS

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

    Pediatric Use

    Safety and effectiveness in pediatric patients have not been established.

    Geriatric Use

    Clinical studies on this product have not been performed to determine whether elderly subjects respond differently from younger subjects.


  • ADVERSE REACTIONS

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


  • DOSAGE AND ADMINISTRATION

    One capsule daily, or as directed by a physician.


  • HOW SUPPLIED

    Supplied in child resistant bottles of 30 capsules (NDC 18860-752-01).

    Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F).


  • KEEP THIS AND ALL DRUGS/MEDICATIONS OUT OF THE REACH OF CHILDREN.

    Distributed by: Azur Pharma Inc. 1818 Market Street, Suite 2350 Philadelphia, PA 19103 www.azurpharma.com

    To report a serious adverse event or obtain product information, contact (800) 890 3098.

    life's DHA logo

    life’sDHA™ is a trademark of Martek Biosciences Corporation.

    Natelle® is a registered trademark of Azur Pharma International II Limited.

    Rx Only

    NAT1w-11-01


  • Principal Display Panel - Bottle

    30 Capsules

    NDC 18860-752-01

    Natelle® ONE

    Rx Prenatal Vitamin & Plant-Based DHA.

    Now with 28 mg Iron

    Rx Only

    Dist by: AZUR PHARMA INC.

    1818 Market Street, Suite 2350

    Philadelphia, PA 19103

    www.azurpharma.com

    Mfg by: Accucaps Industries Ltd

    Windsor, Ontario, Canada

    Natelle® is a registered trademark of Azur Pharma International II Limited.

    Principal Display Panel - Bottle Label

    Bottle Label


  • Principal Display Panel - Physician Sample Kit

    Natelle® ONE

    Rx Prenatal Vitamin & Plant-Based DHA

    NDC 18860-752-00

    ONE PHYSICIAN SAMPLING KIT

    Contains 10 Patient Starter Kits, each containing 3 capsules

    NOT FOR SALE

    RX ONLY

    Distributed by: AZUR PHARMA, INC.
    1818 Market Street, Suite 2350 · Philadelphia, PA 19103 · www.azurpharma.com

    Manufactured by: Accucaps Industries Ltd. Windsor, Ontario, Canada

    Natelle® is a registered trademark of Azur Pharma International II Limited.

    life'sDHAâ„¢ is a trademark of Market Biosciences Corporation.

    Principal Display Panel - Physicians Sample

    Physicians Sample Kit


  • INGREDIENTS AND APPEARANCE
    NATELLE ONE 
    doconexent,icosapent, tricalcium phosphate, ferrous fumarate, ascorbic acid, pyridoxine hydrochloride, alpha-tocopherol, and folic acid capsule, gelatin coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:18860-752
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 250 mg
    ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT 0.625 mg
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666) (CALCIUM - UNII:SY7Q814VUP) TRICALCIUM PHOSPHATE 102 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (IRON - UNII:E1UOL152H7) FERROUS FUMARATE 28 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 30 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 25 mg
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL 30 [iU]
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    Inactive Ingredients
    Ingredient Name Strength
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Product Characteristics
    Color RED Score no score
    Shape CAPSULE (oblong) Size 25mm
    Flavor Imprint Code Natelle1
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:18860-752-01 30 in 1 BOTTLE
    2 NDC:18860-752-00 3 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 06/11/2010
    Labeler - Jazz Pharmaceuticals Commercial Corp. (805611071)