Label: CITRANATAL MEDLEY- calcium citrate, iron pentacarbonyl, ferrous fumarate, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, and doconexent capsule, gelatin coated

  • NDC Code(s): 0178-0896-30
  • 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 February 9, 2021

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

  • BOXED WARNING (What is this?)

    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.

  • WARNINGS

    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.

  • WARNINGS

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

  • DESCRIPTION

    CitraNatal Medley™ is a prescription prenatal/postnatal multi-vitamin/mineral soft gel with Ferr-Ease®, a patented dual-iron delivery comprising both a quick release and slow release iron, and DHA, an essential fatty acid. The prenatal vitamin is an oval, purple, opaque soft gel containing a greenish-grey liquid to semi-solid fill. The prenatal soft gel is printed “896” in white ink.

  • INDICATIONS & USAGE

    CitraNatal Medley is a multi-vitamin/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.

  • 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.

  • DOSAGE & ADMINISTRATION

    One prenatal soft gel daily or as directed by a physician.

  • HOW SUPPLIED

    Bottles of 30 soft gels each - NDC 00178-0896-30.

  • PRINCIPAL DISPLAY PANEL

    Retail Label

  • INGREDIENTS AND APPEARANCE
    CITRANATAL MEDLEY 
    calcium citrate, iron pentacarbonyl, ferrous fumarate, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, and doconexent capsule, gelatin coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0178-0896
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION2 mg
    CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CITRATE ANHYDROUS62 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON27 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL200 [iU]
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL15 [iU]
    PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE12.5 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT200 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN (UNII: 2G86QN327L)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Product Characteristics
    Colorpurple (opaque) Scoreno score
    ShapeCAPSULESize25mm
    FlavorImprint Code 596
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0178-0896-3030 in 1 BOTTLE; Type 0: Not a Combination Product03/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/20/2018
    Labeler - Mission Pharmacal Company (008117095)
    Registrant - Mission Pharmacal Company (927726893)
    Establishment
    NameAddressID/FEIBusiness Operations
    Catalent Ontario Limited243944050manufacture(0178-0896)