ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS:. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.. PEDIATRIC USE:. Safety and effectiveness in pediatric patients have not been established.. GERIATRIC USE:. Clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
CONTRAINDICATIONS:. This product is contraindicated in patients with known hypersensitivity to any of the ingredients.
DESCRIPTION:. INATAL Ultra is white, dye free, oval oil-and-water-soluble multivitamin/multimineral tablet with calcium citrate and carbonyl iron.Each tablet contains:Vitamin . . . . . . . . . . . . 2700 I.U.Vitamin (Ascorbic Acid) . . . . . . . 120 mgCalcium (Calcium Citrate) . . . . . . 200 mgElemental Iron (Carbonyl Iron) . . . . . 90 mgVitamin D3 (Cholecalciferol) . . . . . . 400 I.U.Vitamin (dl-Alpha Tocopheryl Acetate) . . 30 I.U.Vitamin B1 (Thiamine Mononitrate) . . . . 3 mgVitamin B2 (Riboflavin) . . . . . . . . 3.4 mgNiacinamide . . . . . . . . . . . . 20 mgVitamin B6 (Pyridoxine HCI) . . . . . . 20 mgFolic Acid . . . . . . . . . . . . . 1 mgVitamin B12 (Cyanocobalamin) . . . . . 12 mcgIodine (Potassium Iodide) . . . . . . 150 mcgZinc (Zinc Oxide) . . . . . . . . . . 25 mgCopper (Cupric Oxide) . . . . . . . . 2 mgDocusate Sodium . . . . . . . . . . 50 mgInput as Vitamin palmitate and beta carotene.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION:. One tablet daily or as directed by physician.
HOW SUPPLIED SECTION.
HOW SUPPLIED:. NDC 63044-154-63 Unit Dose Packs containing 10 tablets per card.Store at controlled room temperature 15-30C (59-86F).KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.Manufactured for Nnodum PharmaceuticalCincinnati, Ohio 45229.
INDICATIONS & USAGE SECTION.
INDICATIONS:. INATAL Ultra (R) is multivitamin/multimineral nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Ultra NatalCare(R) can also be beneficial in improving the nutritional status of women prior to conception.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL. 4b22195d-figure-01. 4b22195d-figure-02.
PRECAUTIONS:. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
SPL UNCLASSIFIED SECTION.
Prenatal Multivitamin/Multimineral Tablets63044-154-63Rx OnlyWARNING: Accidental overdose of iron-containing prod-Ucts 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.
WARNINGS:. Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.NOTICE: Contact with moisture may produce surface discoloration or erosion of the tablet.