Label: CITRANATAL ASSURE- ascorbic acid, calcium citrate, iron, vitamin d, dl- alpha- tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper, docusate sodium, doconexent and icosapent

  • NDC Code(s): 0178-0891-10, 0178-0891-30
  • 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 October 22, 2018

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 Assure ® 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, coated, oval multivitamin/mineral tablet. The tablet is debossed "0891" 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 capsule contains:
    Vitamin C (Ascorbic acid) 120   mg
    Calcium (Calcium citrate) 124 mg
    Iron (Carbonyl iron, ferrous gluconate) 35   mg
    Vitamin D 3 (Cholecalciferol) 400   IU
    Vitamin E (dl-alpha tocopheryl acetate) 30   IU
    Thiamin (Vitamin B 1) 3   mg
    Riboflavin (Vitamin B 2) 3.4   mg
    Niacinamide (Vitamin B 3) 20   mg
    Vitamin B 6 (Pyridoxine HCl) 25   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: Gelatin, sunflower oil, glycerin, caramel color, sunflower lecithin, rosemary extract, tocopherols, ascorbyl palmitate.

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  • INDICATIONS

    CitraNatal Assure ® 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.

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  • WARNING

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 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.

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  • SPL UNCLASSIFIED SECTION

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

    51062
    C01 Rev 010130

    Mission®
    PHARMACAL

    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

    Copyright © 2013 Mission Pharmacal Company.

    All rights reserved.

    www.missionpharmacal.com

    Ferr-Ease®
    Dual-iron delivery

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

    life's DHA®

    life’sDHA is a trademark of DSM.
    U.S. Patent No. 7,579,174
    U.S. Patent No. 7,732,170
    U.S. Patent No. 5,518,918

    *March of Dimes does not endorse
    specific products or brands.
    March of Dimes is a registered trademark
    of the March of Dimes Foundation.

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  • HOW SUPPLIED

    Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0891-30

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  • PRINCIPAL DISPLAY PANEL

    CitraNatal Assure Sample Blister Pack
    NDC 0178–0891–10

    CitraNatal Assure Sample Blister
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  • PRINCIPAL DISPLAY PANEL

    5-Day Sample Pack Carton

    5-Day Sample Carton
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  • PRINCIPAL DISPLAY PANEL

    6-Count Sample Pack Display

    Sample Display
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  • PRINCIPAL DISPLAY PANEL

    CitraNatal Assure Retail Blister Pack
    NDC 0178–0891–30

    Retail Blister
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  • PRINCIPAL DISPLAY PANEL

    Retail Carton

    citra-natal-assure-carton-0178-0891-30
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  • INGREDIENTS AND APPEARANCE
    CITRANATAL ASSURE 
    ascorbic acid, calcium citrate, iron, vitamin d, dl- alpha- tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper, docusate sodium, doconexent and icosapent kit
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0178-0891
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0178-0891-10 5 in 1 CARTON 04/30/2014
    1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:0178-0891-30 30 in 1 CARTON 04/30/2014
    2 1 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1
    Part 2
    Part 1 of 2
    PRENATAL VITAMIN 
    ascorbic acid, calcium citrate, iron, vitamin d, dl- alpha- tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper and docusate sodium tablet, coated
    Product Information
    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
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 35 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU]
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) (ALPHA-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL 30 [iU]
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3.4 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 25 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 150 ug
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 25 mg
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 2 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 3 mg
    CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CITRATE ANHYDROUS 124 mg
    Inactive Ingredients
    Ingredient Name Strength
    POVIDONE K30 (UNII: U725QWY32X)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SHELLAC (UNII: 46N107B71O)  
    VANILLIN (UNII: CHI530446X)  
    Product Characteristics
    Color white Score no score
    Shape OVAL Size 20mm
    Flavor Imprint Code 0891
    Contains     
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 11/19/2008
    Part 2 of 2
    DHA 
    doconexent and icosapent capsule
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 300 mg
    ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT 0.75 mg
    Inactive Ingredients
    Ingredient Name Strength
    GELATIN (UNII: 2G86QN327L)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    ROSEMARY (UNII: IJ67X351P9)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    Product Characteristics
    Color orange (caramel color) Score no score
    Shape CAPSULE Size 23mm
    Flavor Imprint Code
    Contains     
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 11/19/2008
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 04/30/2014
    Labeler - Mission Pharmacal Company (008117095)
    Registrant - Mission Pharmacal Company (927726893)
    Establishment
    Name Address ID/FEI Business Operations
    Mission Pharmacal Company 927726893 manufacture(0178-0891)
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