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 kit

  • NDC Code(s): 0178-0891-30
  • Packager: Mission Pharmacal Company
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated October 27, 2022

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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)124mg
    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 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, sunflower oil, glycerin, caramel color, sunflower lecithin, rosemary extract, tocopherols, ascorbyl palmitate.

  • 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.

  • CONTRAINDICATIONS

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

  • 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.

  • 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.

  • SPL UNCLASSIFIED SECTION

    CAUTION: Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

  • STORAGE

    Store at 20–25°C (68–77°F)

    NOTICE

    Contact with moisture can discolor or erode the tablet.

  • SPL UNCLASSIFIED SECTION

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

    51062R1120

    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 © 2020 Mission Pharmacal Company.

    All rights reserved.


  • HOW SUPPLIED

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

  • PRINCIPAL DISPLAY PANEL

    CitraNatal Assure Retail Blister Pack
    NDC 0178–0891–30

    Retail Blister
  • PRINCIPAL DISPLAY PANEL

    LabelRetail Carton

  • 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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0178-0891
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0178-0891-3030 in 1 CARTON04/30/2014
    11 in 1 BLISTER PACK; Type 1: Convenience Kit of Co-Package
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1 1 
    Part 2 1 
    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 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) IRON35 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) (ALPHA-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL30 [iU]
    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 HYDROCHLORIDE25 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE150 ug
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC25 mg
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER2 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
    CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CITRATE ANHYDROUS124 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorwhiteScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code 0891
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/19/2008
    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) DOCONEXENT300 mg
    ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT0.75 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    Colororange (caramel color) Scoreno score
    ShapeCAPSULESize23mm
    FlavorImprint Code
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/19/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/30/2014
    Labeler - Mission Pharmacal Company (008117095)
    Registrant - Mission Pharmacal Company (927726893)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mission Pharmacal Company927726893manufacture(0178-0891)
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Boxed Warnings, Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

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