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): 0178-0821-30
  • 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 April 6, 2020

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.

  • KEEP OUT OF REACH OF CHILDREN

  • 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 white, oval multivitamin/mineral tablet. The tablet is debossed “CN 90” on one side and “0821” 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)159 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 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 750 mg Algal Oil)300 mg
    Eicosapentaenoic Acid (EPA)Not more than 0.750 mg

    Other ingredients in DHA gelatin capsule: Gelatin, glycerin, sunflower oil, water, caramel color, tocopherols, rosemary extract, sunflower lecithin, ascorbyl palmitate.

  • INACTIVE INGREDIENT

  • PURPOSE

  • 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.

  • CONTRAINDICATIONS

    This product is contraindicated 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.

  • 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 0178-0821-30

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

    Please consult your health care provider with any dietary concerns.



    51072

    C01 Rev 011130


    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

    Ferr-Ease™
    Dual-iron delivery

    Trademark of Mission Pharmacal Company
    U.S. Patent No. 6,521,247

    life's DHA™
    HEALTHY BRAIN, EYES, HEART

  • PRINCIPAL DISPLAY PANEL


    CitraNatal ®90 DHA Carton
    NDC: 0178-0821-30

    citranatal-90-dha-carton
  • 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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0178-0821
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON85 mg
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL30 [iU]
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 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
    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
    CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CITRATE159 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE4.54 mg
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE150 ug
    FERROUS GLUCONATE (UNII: U1B11I423Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION5 mg
    VITAMIN D (UNII: 9VU1KI44GP) (VITAMIN D - UNII:9VU1KI44GP) VITAMIN D400 [iU]
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3.4 mg
    Product Characteristics
    Colorbrown (caramel) Score2 pieces
    ShapeCAPSULESize10mm
    FlavorImprint Code CN;90;0821
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0178-0821-306 in 1 CARTON04/11/2014
    15 in 1 BLISTER PACK
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/11/2014
    Labeler - Mission Pharmacal Company (008117095)
    Registrant - Mission Pharmacal Company (927726893)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mission Pharmacal Company927726893manufacture(0178-0821)