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

  • NDC Code(s): 0178-0893-30
  • 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 May 19, 2011

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 "0893" on one side and is blank on the other. The essential fatty acid DHA capsule is clear and contains an amber to light/dark orange semi-solid mixture.

    Each prenatal capsule contains:
    Vitamin C (Ascorbic acid) 120   mg
    Calcium (Calcium citrate) 125   mg
    Iron (Carbonyl iron, ferrous gluconate) 35   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) 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) 300   mg
    Eicosapentaenoic Acid (EPA) Not more than 0.750   mg

    DHA is contained in the oil derived from microalgae.

    Other ingredients in DHA gelatin capsule: Gelatin, Glycerin USP, Water.

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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 B12 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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  • CAUTION

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

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  • DOSAGE AND ADMINISTRATION

    One tablet and one capsule daily or as directed by a physician.

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  • STORAGE AND HANDLING

    Store at controlled room temperature.

    NOTICE

    Contact with moisture can discolor or erode the tablet.

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  • HOW SUPPLIED

    Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0893-30

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  • SPL UNCLASSIFIED SECTION

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

    50289
    C02 Rev 010090

    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

    www.missionpharmacal.com

    Copyright © 2009 Mission Pharmacal Company.

    All rights reserved.

    Ferr-Ease
    Dual-iron delivery

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

    life's DHA
    HEALTHY BRAIN, EYES, HEART

    Trademark of Martek Biosciences Corporation
    U.S. Patent No. 5,407,957
    U.S. Patent No. 5,492,938

    *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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  • PRINCIPAL DISPLAY PANEL - Six 5-day Blister Pack Carton

    Rx Only
    NDC
    0178-0893-30

    Its gentle nature
    is its strength

    CitraNatalAssure®

    Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule

    An Rx prenatal
    vitamin and
    omega-3 (DHA)
    derived from an
    all natural
    plant source

    march of dimes®

    Mission Pharmacal is a proud
    supporter of the March of Dimes.*

    CONTAINS
    Six 5-day Blister Packs

    Mission®
    PHARMACAL

    PRINCIPAL DISPLAY PANEL - Six 5-day Blister Pack Carton
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  • INGREDIENTS AND APPEARANCE
    CITRANATAL ASSURE 
    ascorbic acid, calcium citrate, iron, vitamin d, .alpha.-tocopherol acetate, dl-, 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:0178-0893
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0178-0893-30 6 in 1 CARTON
    1 1 in 1 BLISTER PACK
    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, .alpha.-tocopherol acetate, dl-, 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
    calcium citrate (UNII: MLM29U2X85) (calcium - UNII:SY7Q814VUP) calcium citrate 125 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]
    Thiamine (UNII: X66NSO3N35) (Thiamine - UNII:X66NSO3N35) Thiamine 3 mg
    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
    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 0893
    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)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    Color ORANGE (clear, amber to light/dark orange) 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 11/19/2008
    Labeler - Mission Pharmacal Company (008117095)
    Establishment
    Name Address ID/FEI Business Operations
    Accucaps Industries Ltd 248441727 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Mission Pharmacal Company 927726893 MANUFACTURE
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