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

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 21, 2013

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  • 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.

  • DESCRIPTION

    CitraNatal® Rx is a scored white oval multivitamin/multimineral tablet. The tablet is debossed “CN RX” on one side and is blank on the other.

    Each 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
  • INDICATIONS

    CitraNatal® Rx is a multivitamin/multimineral 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

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

    NOTICE: Contact with moisture can produce surface discoloration or erosion of the tablet.

  • 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 daily or as directed by a physician. DISPENSE IN A TIGHT, LIGHT RESISTANT CONTAINER AS DEFINED BY THE USP/NF WITH A CHILD RESISTANT CLOSURE. Store at controlled room temperature.

    L085990

    C02 Rev 005080


    MISSION PHARMACAL COMPANY
    San Antonio, TX USA 78230 1355

  • PRINCIPAL DISPLAY PANEL

    CitraNatal® Rx Label
    NDC: 0178-0859-90

    cnrx-0508-label-ndc-0178-0859-90-c02-l085990-90cnt-cln
  • INGREDIENTS AND APPEARANCE
    CITRANATAL RX 
    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:0178-0859
    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
    FERROUS GLUCONATE (UNII: U1B11I423Z) 61.7 mg
    ALPHA-TOCOPHERYLQUINONE (UNII: ZO763K43XR) 35.2 mg
    MAGNESIUM SILICATE (UNII: 9B9691B2N9) 10.38 mg
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) 1.98 mg
    ETHYL VANILLIN (UNII: YC9ST449YJ) .66 mg
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeOVALSize10mm
    FlavorImprint Code CN;RX
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0178-0859-9090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other11/26/2007
    Labeler - Mission Pharmacal Company (008117095)
    Registrant - Mission Pharmacal Company (927726893)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mission Pharmacal Company927726893MANUFACTURE(0178-0859)
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