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 leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call doctor or poison control center immediately.
CONTRAINDICATIONS. [Insert Mechanism of Action text here].
DESCRIPTION. CitraNatal(R) DHA is prescription prenatal/postnatal multivitamin/mineral tablet with Ferr-Ease(R), patented dual-iron delivery comprising both quick release and slow release iron, and capsule of an essential fatty acid. The prenatal vitamin is white, scored, oval multivitamin/mineral tablet. The tablet is debossed CN RX on one side and is blank on the other. The essential fatty acid DHA capsule is caramel colored and contains light yellow to orange semi-solid mixture.Each prenatal tablet contains:Vitamin (Ascorbic acid)120 mgCalcium (Calcium citrate)125 mgIron (Carbonyl iron, ferrous gluconate)27 mgVitamin D3 (Cholecalciferol)400 IUVitamin (dl-alpha tocopheryl acetate)30 IUThiamin (Vitamin B1)3 mgRiboflavin (Vitamin B2)3.4 mgNiacinamide (Vitamin B3)20 mgVitamin B6 (Pyridoxine)20 mgFolic Acid1 mgIodine (Potassium iodide)150 mcgZinc (Zinc oxide)25 mgCopper (Cupric oxide)2 mgDocusate Sodium50 mgEach DHA gelatin capsule contains:Docosahexaenoic Acid ((DHA, 40% from 625 mg Algal Oil) 250 mg Eicosapentaenoic Acid (EPA)................. Not more than 0.625 mg Other ingredients in DHA gelatin capsule: High Oleic Sunflower Oil, Sunflower Lecithin, Rosemary Extract, Tocopherols, Ascorbyl Palmitate.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION. One tablet and one capsule daily or as directed by physician.
HOW SUPPLIED SECTION.
HOW SUPPLIED. Six child-resistant blister packs of tablets and capsules each NDC 0178-0898-30To report serious adverse event or obtain product information, call (210) 696-8400.500238C01 Rev 011110DHA capsules manufactured for:MISSION PHARMACAL COMPANYSan Antonio, TX USA 78230 1355 Prenatal tablets manufactured by:MISSION PHARMACAL COMPANYSan Antonio, TX USA 78230 1355.
INDICATIONS & USAGE SECTION.
INDICATIONS. [Insert Clinical Pharmacology General text here]. CONTRAINDICATIONS. [Insert Mechanism of Action text here].
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
CitraNatal(R) DHA CartonNDC: 0178-0898-30. CitraNatal DHA Carton.
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.
WARNING. Ingestion of more than 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.