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

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 January 7, 2021

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.

  • DESCRIPTION:

    CitraNatal Bloom TM is 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)90 mg
    Folic Acid1 mg
    Vitamin B 12 (Cyanocobalamin) 12 mcg
    Vitamin C (Ascorbic acid)120mg
    Docusate sodium50 mg

    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 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.

  • 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 — ( NDC 0178-0813-30).

  • 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

  • PRINCIPAL DISPLAY PANEL

    CitraNatal Bloom 90 Label

    citranatal-bloom-label-1
  • 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 other08/01/2017
    Labeler - Mission Pharmacal Company (008117095)
    Registrant - Mission Pharmacal Company (927726893)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mission Pharmacal Company927726893manufacture(0178-0813)