Label: CITRANATAL HARMONY- calcium citrate, iron pentacarbonyl, cholecalciferol, alpha-tocopherol, dl-, pyridoxine hydrochloride, folic acid, docusate sodium, and doconexent capsule, gelatin coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Drug Label Information

Updated May 3, 2010

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  • DESCRIPTION

    CitraNatal® Harmony™ is a prescription prenatal/postnatal multivitamin/mineral soft gelatin capsule. The prenatal vitamin is a purple, opaque soft gelatin capsule containing a greenish-gray liquid to semi-solid fill. The capsule is printed "0812" in white ink.

    Each prenatal capsule contains:

    Calcium (Calcium citrate)100 mgVitamin B6 (Pyridoxine HCl)25 mg
    Iron (Carbonyl iron)27 mgFolic Acid1 mg
    Vitamin D3 (Cholecalciferol)400 IUDocusate Sodium50 mg
    Vitamin E (dl-alpha tocopheryl acetate)30 IUDocosahexaenoic Acid (DHA)250 mg

    DHA is contained in the oil derived from microalgae.

  • INDICATIONS

    CitraNatal® Harmony™ 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.

  • 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. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

  • WARNING

    Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an 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.

  • WARNING

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

  • PRECAUTIONS

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

  • ADVERSE REACTIONS

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

    CAUTION: Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

  • DOSAGE AND ADMINISTRATION

    One capsule daily or as directed by a physician.

    Store at controlled room temperature.

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

  • HOW SUPPLIED

    Bottles of 30 capsules each - NDC 0178-0812-30.

  • SPL UNCLASSIFIED SECTION

    To report a serious adverse event or obtain product information, call (210) 696-8400.

    life'sDHA™

    Trademark of Martek Biosciences Corporation
    U.S. Patent No. 5,407,957
    U.S. Patent No. 5,492,938

    Manufactured for:
    MISSION PHARMACAL COMPANY
    San Antonio, TX USA 78230 1355

    www.missionpharmacal.com

    Copyright © 2009 Mission Pharmacal Company. All rights reserved.

  • PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Carton

    The one-pill solution
    for gentle prenatal nutrition

    Rx Only
    NDC     0178-0812-05

    CitraNatal® Harmony™
    Rx Prenatal Vitamin Gel Cap

    • Convenient, one-dose prenatal nutrition
      in a vanilla-scented gel cap
       
    • Gentle calcium citrate and carbonyl iron,
      plus a stool softener and natural,
      plant-based DHA

    life'sDHA ™
    HEALTHY BRAIN, EYES, HEART

    5-DAY STARTER PACK
    In Child-Resistant Packaging
    Sample-Not For Sale

    Contains
    Stool Softener

    Mission®
    PHARMACAL

    PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CITRANATAL HARMONY 
    calcium citrate, iron pentacarbonyl, cholecalciferol, alpha-tocopherol, dl-, pyridoxine hydrochloride, folic acid, docusate sodium, and doconexent capsule, gelatin coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0178-0812
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Calcium citrate (UNII: MLM29U2X85) (Calcium - UNII:SY7Q814VUP) Calcium citrate100 mg
    Iron pentacarbonyl (UNII: 6WQ62TAQ6Z) (Iron - UNII:E1UOL152H7) Iron pentacarbonyl27 mg
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol400 [iU]
    Alpha-tocopherol, DL- (UNII: 7QWA1RIO01) (Alpha-tocopherol, DL- - UNII:7QWA1RIO01) Alpha-tocopherol, DL-30 [iU]
    Pyridoxine hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine hydrochloride25 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
    Docusate Sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate Sodium50 mg
    Doconexent (UNII: ZAD9OKH9JC) (Doconexent - UNII:ZAD9OKH9JC) Doconexent250 mg
    Product Characteristics
    ColorPURPLE (opaque) Scoreno score
    ShapeCAPSULESize25mm
    FlavorImprint Code 812
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0178-0812-301 in 1 CARTON
    130 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other04/27/2010
    Labeler - MISSION PHARMACAL COMPANY (008117095)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accucaps Industries Ltd.248441727MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Mission Pharmacal Company927726893MANUFACTURE
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