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 October 22, 2018

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 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.

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  • ACTIVE INGREDIENT

    Iron (Carbonyl iron, ferrous gluconate) 90 mg
    Folic Acid 1 mg
    Vitamin B 12 (Cyanocobalamin) 12 mcg
    Vitamin C (Ascorbic acid) 120 mg
    Docusate sodium 50 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.

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  • 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.

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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:

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemia where vitamin B 12 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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  • DOSAGE AND ADMINISTRATION

    One tablet daily or as directed by a physician.

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  • 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.

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  • NOTICE:

    Contact with moisture can discolor or erode the tablet.

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  • HOW SUPPLIED:

    Bottles of 30 tablets each — ( NDC 0178-0813-30).

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  • 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

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  • PRINCIPAL DISPLAY PANEL

    CitraNatal Bloom 90 Label

    citranatal-bloom-label-1
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  • INGREDIENTS AND APPEARANCE
    CITRANATAL BLOOM 
    iron, folic acid, cyanocobalamin, ascorbic acid, and docusate sodium tablet, film coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0178-0813
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 138 mg
    IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 88.5 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 55 mg
    FERROUS GLUCONATE (UNII: U1B11I423Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 13.2 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1.4 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 16.8 ug
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color green Score no score
    Shape RECTANGLE (modified rectangle) Size 9mm
    Flavor Imprint Code CB
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0178-0813-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 08/01/2017
    Labeler - Mission Pharmacal Company (008117095)
    Registrant - Mission Pharmacal Company (927726893)
    Establishment
    Name Address ID/FEI Business Operations
    Mission Pharmacal Company 927726893 manufacture(0178-0813)
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