INDICATIONS & USAGE SECTION.


INDICATIONS CitraNatal Rx 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.

DOSAGE & ADMINISTRATION SECTION.


DOSAGE AND ADMINISTRATION One tablet daily or as directed by a physician.

SPL UNCLASSIFIED SECTION.


To report a serious adverse event or obtain product information, call (210) 696-8400. MISSION PHARMACAL COMPANYL085890 San Antonio, TX USA 78230 1355C01 Rev 004140

HOW SUPPLIED SECTION.


HOW SUPPLIED Bottles of 90 tablets each - NDC 0178-0858-90.

ADVERSE REACTIONS SECTION.


ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

BOXED WARNING SECTION.


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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


CitraNatal Rx Label NDC: 0178-0858-90

DESCRIPTION SECTION.


DESCRIPTION CitraNatal Rx is a prenatal/postnatal multi-vitamin/mineral tablet with Ferr-Ease, a patented dual-iron delivery comprising both a quick release and slow release iron. CitraNatal Rx is a white, oval tablet debossed CN 1 on one side and blank on the other. Each prenatal tablet contains: Vitamin C (Ascorbic acid) ..............................................................................120 mg Calcium (Calcium citrate) ..............................................................................124 mg Iron (Carbonyl iron, ferrous gluconate) ..............................................................................27 mg Vitamin D3 (Cholecalciferol) ..............................................................................400 IU Vitamin E (dl-alpha tocopheryl acetate) ..............................................................................30 IU Thiamin (Vitamin B1) ..............................................................................3 mg Riboflavin (Vitamin B2) ..............................................................................3.4 mg Niacinamide (Vitamin B3) ..............................................................................20 mg Vitamin B6 (Pyridoxine) ..............................................................................20 mg Folic Acid ..............................................................................1 mg Iodine (Potassium iodide) ..............................................................................150 mcg Zinc (Zinc oxide) ..............................................................................25 mg Copper (Cupric oxide) ..............................................................................2 mg Docusate Sodium ..............................................................................50 mg

PRECAUTIONS SECTION.


PRECAUTIONS Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

STORAGE AND HANDLING SECTION.


STORAGE Store at 20-25C (68-77F) [See USP controlled room temperature].

WARNINGS SECTION.


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