BOXED WARNING SECTION.
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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
CitraNatal 90 DHA Carton NDC: 0178-0829-30
OTC - ACTIVE INGREDIENT SECTION.
DESCRIPTION CitraNatal 90 DHA is a prescription prenatal/postnatal multivitamin/mineral tablet with Ferr-Ease, a patented dual-iron delivery comprising both a quick release and slow release iron, and a capsule of an essential fatty acid. The prenatal vitamin is a scored, white, oval multivitamin/mineral tablet. The tablet is debossed CN 90 on one side and 08 bisect 29 on the other. The essential fatty acid DHA capsule is caramel colored and contains a light yellow to orange semi-solid mixture. Each prenatal tablet contains: Vitamin C (Ascorbic acid) 120 mg Calcium (Calcium citrate) 160 mg Iron (Carbonyl iron, ferrous gluconate) 90 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 HCl) 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 Each DHA gelatin capsule contains: Docosahexaenoic Acid (DHA, 40% from 750 mg Algal Oil)................................... 300 mg Eicosapentaenoic Acid (EPA) .................. Not more than 0.750 mg Other ingredients in DHA gelatin capsule: High Oleic Sunflower Oil, Sunflower Lecithin, Rosemary Extract, Tocopherols, Ascorbyl Palmitate.
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
INDICATIONS & USAGE SECTION.
indications CitraNatal 90 DHA is a multivitamin/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.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION One tablet and one capsule daily or as directed by a physician.
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) NOTICE: Contact with moisture can discolor or erode the tablet. HOW SUPPLIED Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0829-30 To report a serious adverse event or obtain product information, call (210) 696-8400. 50261 C01 Rev 011110 DHA capsules manufactured for: MISSION PHARMACAL COMPANY San Antonio, TX USA 78230 1355 Prenatal tablets manufactured by: MISSION PHARMACAL COMPANY San Antonio, TX USA 78230 1355
CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
WARNING Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis. WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.