Label: CITRANATAL HARMONY 3.0- calcium citrate, iron pentacarbonyl, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, docusate sodium, and doconexent capsule, gelatin coated

  • NDC Code(s): 0178-0796-30
  • Packager: Mission Pharmacal Company
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 7, 2021

If you are a consumer or patient please visit this version.

  • 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

    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 “0796” in white ink.

    Each prenatal capsule contains:
    Calcium (Calcium citrate)104 mgVitamin B 6 (Pyridoxine HCl)    25    mg
    Iron (Ferrous fumarate, carbonyl iron)   27 mgFolic Acid      1    mg
    Vitamin D 3 (Cholecalciferol) 400 IUDocusate Sodium   50    mg
    Vitamin E (dl-alpha tocopheryl acetate)   30 IUDocosahexaenoic Acid (DHA 40% from 650 mg Algal Oil)260    mg
  • 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 contraindictated in patients with a known hypersensitivity to any of the ingredients.

  • 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 B 12 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 0178-0796-30

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

    Please consult your health care provider with any dietary concerns.




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


  • PRINCIPAL DISPLAY PANEL

    CitraNatal Label
    NDC 0178-0796-30

    citranatal-harmony-30-softgels-carton
  • INGREDIENTS AND APPEARANCE
    CITRANATAL HARMONY 3.0 
    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:0178-0796
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CITRATE ANHYDROUS104 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON27 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL30 [iU]
    PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE25 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) DOCONEXENT260 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    Product Characteristics
    Colorpurple (opaque) Scoreno score
    ShapeCAPSULESize25mm
    FlavorImprint Code 0796
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0178-0796-3030 in 1 BOTTLE; Type 0: Not a Combination Product03/21/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/21/2014
    Labeler - Mission Pharmacal Company (008117095)
    Registrant - Mission Pharmacal Company (927726893)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mission Pharmacal Company927726893pack(0178-0796)