Label: CITRANATAL BLOOM DHA- iron, folic acid, cyanocobalamin, ascorbic acid, docusate sodium and dha kit

  • NDC Code(s): 0178-0816-30
  • 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 April 6, 2020

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    CitraNatal Bloom™ 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 DHA, an essential fatty acid. The prenatal vitamin is a green, modified rectangle shaped, film-coated tablet, debossed with “CB” on one side and blank on the other. The essential fatty acid DHA soft gel is oblong, light brown and contains a yellow to orange fill.

    Each prenatal tablet contains:

    Iron (Carbonyl iron, ferrous gluconate)...........................90 mg

    Folic Acid .........................................................................1 mg

    Vitamin B12 (Cyanocobalamin) ...................................12 mcg

    Vitamin C (Ascorbic acid).............................................120 mg

    Docusate sodium ..........................................................50 mg

  • INACTIVE INGREDIENT

    Povidone, croscarmellose sodium, acrylic resin, color added, FD&C Yellow No. 5, magnesium stearate, magnesium silicate, FD&C Blue No. 1, polyethylene glycol, vitamin A palmitate, ethyl vanillin.

  • INDICATIONS & USAGE

    CitraNatal Bloom 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.

  • WARNINGS AND PRECAUTIONS

    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 B12 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.

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

    Please consult your health care provider with any dietary concerns.

  • ADVERSE REACTIONS

    Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

  • DOSAGE & ADMINISTRATION

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

  • STORAGE AND HANDLING

    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 minimized.

    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 0178-00816-30.

  • SPL UNCLASSIFIED SECTION

    To report a serious adverse event or obtain product information, call (800) 298-1087.

    MISSION PHARMACAL COMPANY, San Antonio, TX 78230 1355

    51080R0717

    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 © 2017 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.

  • PRINCIPAL DISPLAY PANEL

  • PRINCIPAL DISPLAY PANEL

    CitraNatal Bloom DHA blisterSix child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0816-30

  • PRINCIPAL DISPLAY PANEL

    Retail Carton

    Retail Carton

  • INGREDIENTS AND APPEARANCE
    CITRANATAL BLOOM DHA 
    iron, folic acid, cyanocobalamin, ascorbic acid, docusate sodium and dha kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0178-0816
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0178-0816-3030 in 1 CARTON01/18/2018
    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 
    iron, folic acid, cyanocobalamin, ascorbic acid, 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
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
    FERROUS GLUCONATE (UNII: U1B11I423Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION1.5 mg
    IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION88.5 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    Colorgreen (Coated Tablet) Scorescore with uneven pieces
    ShapeRECTANGLE (Modified Rectangle) Size9mm
    FlavorImprint Code CB;blank
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/22/2018
    Part 2 of 2
    DHA 
    dha capsule, liquid filled
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CRYPTHECODINIUM COHNII DHA OIL (UNII: 8ZJ335A17J) (CRYPTHECODINIUM COHNII DHA OIL - UNII:8ZJ335A17J) CRYPTHECODINIUM COHNII DHA OIL300 mg  in 300 mg
    Inactive Ingredients
    Ingredient NameStrength
    ICOSAPENT (UNII: AAN7QOV9EA)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ROSEMARY (UNII: IJ67X351P9)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Product Characteristics
    Colorbrown (Soft gelatin capsule) Scoreno score
    ShapeCAPSULE (Soft gelatin capsule) Size23mm
    FlavorImprint Code none
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT01/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/18/2018
    Labeler - Mission Pharmacal Company (008117095)
    Registrant - Mission Pharmacal Company (922772689)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mission Pharmacal Company927726893manufacture(0178-0816)