CitraNatal Assure Rx Prenatal Supplement Tablet

Formula re: Contains

Description: CitraNatal Assure 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, and a soft gel of DHA, an essential fatty acid. The prenatal vitamin is a white, coated, oval multi-vitamin/mineral tablet. The tablet is debossed “0891” on one side and is blank on the other. The essential fatty acid DHA soft gel is caramel colored and contains a light yellow to orange semi-solid mixture.

Formula re: Type

Indications: CitraNatal Assure 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 re: All Other

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 and one soft gel 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

How supplied: Six child-resistant blister packs of 5 tablets and 5 soft gels each - NDC 0178-0891-30

Precautions re: All Other

To report a serious adverse event or obtain product information, call (800) 531-3333.

General Statements: All Other Content

Please consult your health care provider with any dietary concerns.