DESCRIPTION:. CitraNatal Bloom TM isa prescription prenatal/postnatal multi-vitamin/mineral tablet withFerr-Ease (R), patented dual-iorn deliverycomprising both quick release and slow release iron. CitraNatalBloom is green, modified rectangle shaped, film-coated tablet, debossedwith CB on one side and blank on the other.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION. One tablet daily or as directed by physician.
GENERAL PRECAUTIONS SECTION.
Folic acid in doses above 0.1 mg daily may obscure perniciousanemia in that hematologic remission can occur while neurologicalmanifestations progress.
HOW SUPPLIED SECTION.
HOW SUPPLIED:. Bottles of 30 tablets each -- NDC 0178-0813-30).
INACTIVE INGREDIENT SECTION.
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, vitaminA palmitate, ethyl vanillin.
INDICATIONS & USAGE SECTION.
INDICATIONS. CitraNatal Bloomis multi-vitamin/mineral prescription drug indicated for use inimproving the nutritional status of women prior to conception, throughoutpregnancy, and in the postnatal period for both lactating and nonlactatingmothers.
OTC - ACTIVE INGREDIENT SECTION.
Iron (Carbonyl iron, ferrousgluconate)90 mgFolic Acid1 mgVitamin 12 (Cyanocobalamin) 12 mcgVitamin (Ascorbic acid)120mgDocusate 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, vitaminA palmitate, ethyl vanillin.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
CitraNatalBloom 90 Label. citranatal-bloom-label-1.
PRECAUTIONS:. Folic acid in doses above 0.1 mg daily may obscure perniciousanemia in that hematologic remission can occur while neurologicalmanifestations progress.
SPL UNCLASSIFIED SECTION.
NOTICE:. Contact with moisture can discoloror erode the tablet.
STORAGE AND HANDLING SECTION.
STORAGE:. Store at 20C to 25C (68F to 77F), excursionspermitted between 15C and 30C (between 59F and 86F). Brief exposureto temperatures up to 40C (104F) may be tolerated provided the meankinetic temperature does not exceed 25C (77F); however, such exposureshould be minimized.
WARNING:. Folic acid alone is improper therapy in the treatmentof pernicious anemia and other megaloblastic anemia where vitaminB 12 is deficient.
BOXED WARNING SECTION.
Warning: Accidentaloverdose of iron-containing products is leading causeof fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THEREACH OF CHILDREN. In case of accidental overdose, call doctor orpoison control center immediately.
CONTRAINDICATIONS:. This product is contraindicatedin patients with known hypersensitivity to any of the ingredients.
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS:. Allergic sensitization has been reported followingboth oral and parenteral administration of folic acid.