CitraNatal Bloom

General Statements: All Other Content

NDC 0178-0813-30

General Statements: All Other Content

Rx only

FDA Statement of Identity

Rx Prenatal Supplement Tablet

General Statements: All Other Content

In child-resistant packaging

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N

Formula re: Contains

Description: CitraNatal Bloom is a prescription prenatal/postnatal multi-vitamin/mineral tablet with Ferr-Ease, a patented dual-iron delivery comprising both a quick release and slow release iron.

General Statements: All Other Content

CitraNatal Bloom is a green, modified rectangle shaped, film-coated tablet, debossed with “CB” on one side and blank on the other.

Formula re: Type

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.

Precautions re: All Other

Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Precautions re: Children

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.

Precautions re: All Other

Warning: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 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.

Precautions re: Allergies

Adverse Reactions: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Suggested/Recommended/Usage/Directions

Dosage and Administration: One tablet daily or as directed by a physician.

Storage

Storage: Store at 20(0)C to 25(0)C (68(0)F to 77(0)F), excursions permitted between 15(0)C and 30(0)C (between 59(0)F and 86(0)F). Brief exposure to temperatures up to 40(0)C (104(0)F) may be tolerated provided the mean kinetic temperature does not exceed 25(0)C (77(0)F); however, such exposure should be minimized.

General Statements: All Other Content

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.

General Statements: All Other Content

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

Brand IP Statement(s) re: (c), (TM), (SM)

Ferr-Ease Dual-Iron delivery Trademark of Mission Pharmacal Company U.S. Patent No. 6,521,247

General: Product/Version Code

L081330R0417