Label: CITRANATAL 90 DHA- vitamin c, calcium, iron, vitamin d3, vitamin e, thiamin, riboflavin, niacinamide, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium tablet

  • NDC Code(s): 0178-0829-30
  • Packager: Mission Pharmacal Company
  • Category: HUMAN OTC 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 March 25, 2013

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.

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  • DESCRIPTION

    CitraNatal® 90 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 scored, white, oval multivitamin/mineral tablet. The tablet is debossed “CN 90” on one side and “08” bisect “29” 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) 160 mg
    Iron (Carbonyl iron, ferrous gluconate) 90 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 HCl) 20 mg
    Folic Acid 1 mg
    Iodine (Potassium iodide) 150 mcg
    Zinc (Zinc oxide) 25 mg
    Copper (Cupric oxide) 2 mg
    Docusate Sodium 50 mg

    Each DHA gelatin capsule contains:
    Docosahexaenoic Acid
    (DHA, 40% from 750 mg Algal Oil)................................... 300 mg
    Eicosapentaenoic Acid (EPA) .................. Not more than 0.750 mg
    Other ingredients in DHA gelatin capsule: High Oleic Sunflower Oil, Sunflower Lecithin, Rosemary Extract, Tocopherols, Ascorbyl Palmitate.

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  • indications

    CitraNatal® 90 DHA 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.

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  • CONTRAINDICATIONS

    This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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  • 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.

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  • PRECAUTIONS

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

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  • ADVERSE REACTIONS

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

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  • DOSAGE AND ADMINISTRATION

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

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  • 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 0178-0829-30

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



    50261

    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

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  • PRINCIPAL DISPLAY PANEL


    CitraNatal®90 DHA Carton
    NDC: 0178-0829-30

    ingredient-listing-for-labels-110909
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  • INGREDIENTS AND APPEARANCE
    CITRANATAL 90 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 Type HUMAN OTC DRUG Item Code (Source) NDC:0178-0829
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg
    CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CITRATE 160 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 90 mg
    VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41) VITAMIN D 400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL 30 [iU]
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 3 mg
    RIBOPRINE (UNII: 8EU82FAZ5J) (RIBOPRINE - UNII:8EU82FAZ5J) RIBOPRINE 3.4 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 20 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    POTASSIUM TRIIODIDE (UNII: T66M6Y3KSA) (TRIIODIDE ION - UNII:DA1N05631Q) POTASSIUM TRIIODIDE 150 ug
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 25 mg
    CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 2 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    POVIDONES (UNII: FZ989GH94E) 152.5 mg
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) 60 mg
    FERROUS GLUCONATE (UNII: U1B11I423Z) 44 mg
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 35.9 mg
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 30 mg
    NIACINAMIDE (UNII: 25X51I8RD4) 26.6 mg
    ACRYLIC ACID (UNII: J94PBK7X8S) 23.2 mg
    MAGNESIUM SILICATE (UNII: 9B9691B2N9) 11.8 mg
    MAGNESIUM STEARATE (UNII: 70097M6I30) 5.5 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) 4.54 mg
    SHELLAC (UNII: 46N107B71O) 2.5 mg
    ETHYL VANILLIN (UNII: YC9ST449YJ) 0.4 mg
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) .01 mg
    Product Characteristics
    Color BROWN (caramel) Score 2 pieces
    Shape CAPSULE Size 10mm
    Flavor Imprint Code CN;90
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0178-0829-30 6 in 1 CARTON
    1 5 in 1 BLISTER PACK
    1 5 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 02/01/2010
    Labeler - Mission Pharmacal Company (008117095)
    Registrant - Mission Pharmacal Company (927726893)
    Establishment
    Name Address ID/FEI Business Operations
    Mission Pharmacal Company 927726893 MANUFACTURE(0178-0829)
    Establishment
    Name Address ID/FEI Business Operations
    Robinson Pharma, Inc. 831560578 MANUFACTURE(0178-0829)
    Establishment
    Name Address ID/FEI Business Operations
    Accucaps Industries Limited 248441727 MANUFACTURE(0178-0829)
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