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  5. Label Information: Citranatal Bloom

FDA Label for Citranatal Bloom

View Indications, Usage & Precautions

Table of Contents

    1. BOXED WARNING
    2. DESCRIPTION:
    3. OTC - ACTIVE INGREDIENT
    4. INACTIVE INGREDIENTS:
    5. INDICATIONS
    6. CONTRAINDICATIONS:
    7. WARNING:
    8. GENERAL PRECAUTIONS
    9. ADVERSE REACTIONS:
    10. DOSAGE AND ADMINISTRATION
    11. STORAGE:
    12. NOTICE:
    13. HOW SUPPLIED:
    14. OTHER
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Citranatal Bloom Product Label

The following document was submitted to the FDA by the labeler of this product Mission Pharmacal Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Boxed Warning



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.


Otc - 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.


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.


General 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.


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).


Other



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




MISSION PHARMACAL COMPANY, San Antonio, TX 78230 1355


Package Label.Principal Display Panel



CitraNatal Bloom 90 Label

citranatal-bloom-label-1 - citranatal bloom label 1

citranatal-bloom-label-1 - citranatal bloom label 1


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