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

  • 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 October 23, 2018

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.

  • KEEP OUT OF REACH OF CHILDREN

  • DESCRIPTION

    CitraNatal ® DHA is a prescription prenatal/postnatal multi-vitamin/mineral tablet with Ferr-Ease ®, a patented dual-iron delivery comprising both a quick release and slow release iron, and a soft gel of an essential fatty acid. The prenatal vitamin is a white, scored, oval multi-vitamin/mineral tablet. The tablet is debossed “CN 1” on one side and is blank on the other. The essential fatty acid DHA soft gel is caramel colored and contains a light yellow to orange semi-solid mixture.

  • ACTIVE INGREDIENT

    Each prenatal tablet contains:
    Vitamin C (Ascorbic acid)120 mg
    Calcium (Calcium citrate)124 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 soft gel contains:
    Other ingredients in DHA soft gel: High oleic sunflower oil, sunflower lecithin, rosemary extract, tocopherols, ascorbyl palmitate.
    Docosahexaenoic Acid (DHA, 40% from 625 mg Algal Oil)250 mg
    Eicosapentaenoic Acid (EPA)Not more than 0.625 mg
  • PURPOSE

  • INACTIVE INGREDIENT

  • INDICATIONS

    CitraNatal ® DHA 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.

  • WARNINGS

    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 soft gel daily or as directed by a physician.

  • STORAGE

    Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimalized.

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

  • HOW SUPPLIED

    Six child-resistant blister packs of 5 tablets and 5 soft gels each - NDC 0178-0894-30.

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

    Please consult your health care provider with any dietary concerns.



    500243
    C01 Rev 002140


    DHA soft gels manufactured for:
    MISSION PHARMACAL COMPANY
    San Antonio, TX USA 78230 1355
    Prenatal tablets manufactured by:
    MISSION PHARMACAL COMPANY
    San Antonio, TX USA 78230 1355

    Copyright © 2014 Mission Pharmacal Company.
    All rights reserved.

  • PRINCIPAL DISPLAY PANEL

    Citranatal DHA
    Rx Prenatal Vitamin Tablet
    and 250 mg DHA Soft Gel
    Carton

    NDC 0178–0894–30

    citra-natal-dha-carton-0178-0894-30
  • PRINCIPAL DISPLAY PANEL

    Blister Pack

    Citranatal DHA - Blisters
  • 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 kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0178-0894
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0178-0894-3030 in 1 CARTON05/22/2014
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1
    Part 2
    Part 1 of 2
    PRENATAL VITAMIN 
    vitamin c, calcium, iron, vitamin d3, vitamin e, thiamin, riboflavin, niacinamide, vitamin b6, folic acid, iodine, zinc, copper, docusate sodium tablet
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41) VITAMIN D400 [iU]
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON27 mg
    .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
    CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CITRATE124 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    SHELLAC (UNII: 46N107B71O)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Product Characteristics
    Colorwhite (white to off white) Scoreno score
    ShapeOVAL (modified oval) Size20mm
    FlavorImprint Code CN;1
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/22/2014
    Part 2 of 2
    DHA 
    doconexent and icosapent capsule
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT250 mg
    ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT0.625 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    ROSEMARY (UNII: IJ67X351P9)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    Product Characteristics
    Colorbrown (caramel) Scoreno score
    ShapeCAPSULESize23mm
    FlavorImprint Code
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT05/22/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/22/2014
    Labeler - Mission Pharmacal Company (008117095)
    Registrant - Mission Pharmacal Company (927726893)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mission Pharmacal Company927726893manufacture(0178-0894)