Label: CITRANATAL BLOOM- iron, folic acid, cyanocobalamin, ascorbic acid, and docusate sodium tablet, film coated

  • NDC Code(s): 0178-0813-30
  • 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 June 29, 2023

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  • BOXED WARNING (What is this?)

    Warning:Accidental overdose of iron-containingproducts 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.

  • DESCRIPTION:

    CitraNatal Bloom TMis a prescription prenatal/postnatal multi-vitamin/mineral tablet with Ferr-Ease ®, a patented dual-iorn delivery comprising both a quick release and slow release iron. CitraNatal Bloom is a green, modified rectangle shaped, film-coated tablet, debossed with “CB” on one side and blank on the other.

  • ACTIVE INGREDIENT

    Iron (Carbonyl iron, ferrous gluconate)90mg
    Folic Acid1mg
    Vitamin B 12(Cyanocobalamin) 12mcg
    Vitamin C (Ascorbic acid)120mg
    Docusate sodium50mg

    Inactive Ingredients:

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

  • CLINICAL PHARMACOLOGY

  • INDICATIONS

    CitraNatal Bloom 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.

  • WARNING:

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

  • DRUG INTERACTIONS

  • OVERDOSAGE

  • DOSAGE AND ADMINISTRATION

    One tablet 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 minimized.

  • NOTICE:

    Contact with moisture can discolor or erode the tablet.

  • HOW SUPPLIED:

    Bottles of 30 tablets each — ( NDC0178-0813-30).

  • SPL UNCLASSIFIED SECTION

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

    MISSION PHARMACAL COMPANY, San Antonio, TX 78230 1355

  • PRINCIPAL DISPLAY PANEL

    CitraNatal Bloom Label

    Label

  • INGREDIENTS AND APPEARANCE
    CITRANATAL BLOOM 
    iron, folic acid, cyanocobalamin, ascorbic acid, and docusate sodium tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0178-0813
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID138 mg
    IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION88.5 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM55 mg
    FERROUS GLUCONATE (UNII: U1B11I423Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION13.2 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1.4 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN16.8 ug
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeRECTANGLE (modified rectangle) Size9mm
    FlavorImprint Code CB
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0178-0813-3030 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/01/201706/01/2024
    Labeler - Mission Pharmacal Company (008117095)
    Registrant - Mission Pharmacal Company (927726893)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mission Pharmacal Company927726893manufacture(0178-0813)
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