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Natelle One (Azur Pharma, Inc.)

Available Formats

Dosage Form Package Information Links
CAPSULE, GELATIN COATED 30 CAPSULE, GELATIN COATED in 1 BOTTLE (18860-852-01) Label Information
CAPSULE, GELATIN COATED 5 CAPSULE, GELATIN COATED in 1 BLISTER PACK (18860-852-00) 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.
    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)...................................................100 mg

    Iron (Ferrous Fumarate) ..................................................................27 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 the oils of microalgae.

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


  • INDICATIONS AND USAGE

    Natelle® One is indicated to provide vitamin/mineral and 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 0.1mg 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

    Natelle® One capsules for oral administration are supplied as oblong red soft gelatin capsules, imprinted with "Natelle1" in white ink, in bottles of 30 capsules (NDC 18860-852-01).

    Store at controlled room temperature 15°-30°C (59°-86°F).


  • KEEP THIS AND ALL DRUGS 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’sDHA™ is a trademark of Martek Biosciences Corporation.

    Natelle® is a registered trademark of Pharmelle.

    Rx Only

    NAT1-09-01


  • BOTTLE LABEL

    Natelle One Bottle Label

  • STARTER KIT LABEL

    Natelle One Starter Kit Label

  • INGREDIENTS AND APPEARANCE
    NATELLE ONE 
    natelle one capsule, gelatin coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:18860-852
    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 100 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (IRON - UNII:E1UOL152H7) FERROUS FUMARATE 27 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, D- (UNII: N9PR3490H9) (ALPHA-TOCOPHEROL, D- - UNII:N9PR3490H9) ALPHA-TOCOPHEROL, D- 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)  
    WAX, YELLOW (UNII: 2ZA36H0S2V)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    Product Characteristics
    Color red Score no score
    Shape CAPSULE (oblong) Size 25mm
    Flavor Imprint Code Natelle;1
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:18860-852-00 5 in 1 BLISTER PACK
    2 NDC:18860-852-01 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other na 11/09/2009
    Labeler - Azur Pharma, Inc. (805611071)
    Establishment
    Name Address ID/FEI Business Operations
    Accucaps Industries Limited 248441727 manufacture