Label: CITRANATAL DHA- vitamin c, calcium, iron, vitamin d3, vitamin e, thiamin, riboflavin, niacinamide, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium tablet

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated March 25, 2013

If you are a healthcare professional or from the pharmaceutical industry 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.

  • KEEP OUT OF REACH OF CHILDREN

  • DESCRIPTION

    CitraNatal® DHA is a prescription prenatal/postnatal multivitamin/mineral tablet with Ferr-Ease®, a patented dual-iron delivery comprising both a quick release and slow release iron, and a capsule of an essential fatty acid. The prenatal vitamin is a white, scored, oval multivitamin/mineral tablet. The tablet is debossed “CN RX” on one side and is blank on the other. The essential fatty acid DHA capsule is caramel colored and contains a light yellow to orange semi-solid mixture.

    Each prenatal tablet contains:
    Vitamin C (Ascorbic acid)120 mg
    Calcium (Calcium citrate)125 mg
    Iron (Carbonyl iron, ferrous gluconate)27 mg
    Vitamin D3 (Cholecalciferol)400 IU
    Vitamin E (dl-alpha tocopheryl acetate)30 IU
    Thiamin (Vitamin B1)3 mg
    Riboflavin (Vitamin B2)3.4 mg
    Niacinamide (Vitamin B3)20 mg
    Vitamin B6 (Pyridoxine)20 mg
    Folic Acid1 mg
    Iodine (Potassium iodide)150 mcg
    Zinc (Zinc oxide)25 mg
    Copper (Cupric oxide)2 mg
    Docusate Sodium50 mg

    Each DHA gelatin capsule contains:
    Docosahexaenoic Acid ((DHA, 40% from 625 mg Algal Oil) 250 mg Eicosapentaenoic Acid (EPA)................. Not more than 0.625 mg Other ingredients in DHA gelatin capsule: High Oleic Sunflower Oil, Sunflower Lecithin, Rosemary Extract, Tocopherols, Ascorbyl Palmitate.

  • ACTIVE INGREDIENT

  • PURPOSE

  • INACTIVE INGREDIENT

  • INDICATIONS

    [Insert Clinical Pharmacology General text here]

    CONTRAINDICATIONS

    [Insert Mechanism of Action text here]

  • 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.

  • DOSAGE AND ADMINISTRATION

    One tablet and one capsule daily or as directed by a physician.

  • STORAGE

    Store at 20-25°C (68-77°F)

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

  • HOW SUPPLIED

    Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0898-30

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

    500238

    C01 Rev 011110


    DHA capsules manufactured for:
    MISSION PHARMACAL COMPANY
    San Antonio, TX USA 78230 1355

    Prenatal tablets manufactured by:
    MISSION PHARMACAL COMPANY
    San Antonio, TX USA 78230 1355

  • PRINCIPAL DISPLAY PANEL

    CitraNatal® DHA Carton
    NDC: 0178-0898-30

    CitraNatal DHA Carton
  • INGREDIENTS AND APPEARANCE
    CITRANATAL DHA 
    vitamin c, calcium, iron, vitamin d3, vitamin e, thiamin, riboflavin, niacinamide, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0178-0898
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CITRATE125 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON27 mg
    VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41) VITAMIN D400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL30 [iU]
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3.4 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE20 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE150 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 mg
    CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONES (UNII: FZ989GH94E) 132.2 mg
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 30.6 mg
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 30.5 mg
    NIACINAMIDE (UNII: 25X51I8RD4) 25 mg
    MAGNESIUM SILICATE (UNII: 9B9691B2N9) 5.1 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) 3.9 mg
    SHELLAC (UNII: 46N107B71O) 2.6 mg
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) 2 mg
    ETHYL VANILLIN (UNII: YC9ST449YJ) .7 mg
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) .15 mg
    VITAMIN D (UNII: 9VU1KI44GP) .02 mg
    Product Characteristics
    ColorBROWN (caramel) Score2 pieces
    ShapeCAPSULESize10mm
    FlavorImprint Code CN;RX
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0178-0898-306 in 1 CARTON
    15 in 1 BLISTER PACK
    15 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other11/20/2007
    Labeler - Mission Pharmacal Company (008117095)
    Registrant - Mission Pharmacal Company (927726893)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mission Pharmacal Company927726893MANUFACTURE(0178-0898)
    Establishment
    NameAddressID/FEIBusiness Operations
    Robinson Pharma, Inc.831560578MANUFACTURE(0178-0898)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accucaps Industries Limited248441727MANUFACTURE(0178-0898)