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INATAL Ultra (Nnodum Pharmaceuticals)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 100 TABLET, COATED in 1 BOTTLE (63044-154-01) Label Information
TABLET, COATED 10 BLISTER PACK in 1 BOX, UNIT-DOSE (63044-154-63) > 10 TABLET, COATED in 1 BLISTER PACK Label Information

Complete INATAL Ultra Information

  • SPL UNCLASSIFIED SECTION

    Prenatal Multivitamin/
    Multimineral Tablets
    63044-154-63

    Rx Only

    WARNING: Accidental overdose of iron-containing prod-Ucts 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.

  • DESCRIPTION:

    INATAL Ultra is a white, dye free, oval oil-and-water-soluble multivitamin/multimineral tablet with calcium citrate and carbonyl iron.

    Each tablet contains:

    Vitamin A* . . . . . . . . . . . . . . . . . . . . . . . 2700 I.U.

    Vitamin C (Ascorbic Acid) . . . . . . . . . . . . . . 120 mg

    Calcium (Calcium Citrate) . . . . . . . . . . . . . 200 mg

    Elemental Iron (Carbonyl Iron) . . . . . . . . . . . 90 mg

    Vitamin D3 (Cholecalciferol) . . . . . . . . . . . . 400 I.U.

    Vitamin E (dl-Alpha Tocopheryl Acetate) . . . . . 30 I.U.

    Vitamin B1 (Thiamine Mononitrate) . . . . . . . . . 3 mg

    Vitamin B2 (Riboflavin) . . . . . . . . . . . . . . . . 3.4 mg

    Niacinamide . . . . . . . . . . . . . . . . . . . . . . . . 20 mg

    Vitamin B6 (Pyridoxine HCI) . . . . . . . . . . . . . 20 mg

    Folic Acid . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 mg

    Vitamin B12 (Cyanocobalamin) . . . . . . . . . . 12 mcg

    Iodine (Potassium Iodide) . . . . . . . . . . . . . 150 mcg

    Zinc (Zinc Oxide) . . . . . . . . . . . . . . . . . . . . . 25 mg

    Copper (Cupric Oxide) . . . . . . . . . . . . . . . . . 2 mg

    Docusate Sodium . . . . . . . . . . . . . . . . . . . . 50 mg

    *Input as Vitamin A palmitate and beta carotene.


  • INDICATIONS:

    INATAL Ultra ® is a 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® can also be beneficial in improving the nutritional status of women prior to conception.


  • CONTRAINDICATIONS:

    This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.


  • 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.


  • PRECAUTIONS:

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


  • 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.


  • DOSAGE AND ADMINISTRATION:

    One tablet daily or as directed by a physician.


  • HOW SUPPLIED:

    NDC 63044-154-63 Unit Dose Packs containing 10 tablets per card.

    Store at controlled room temperature 15°-30°C (59°-86°F).

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

    Manufactured for
    Nnodum Pharmaceutical
    Cincinnati, Ohio 45229


  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    4b22195d-figure-01
    4b22195d-figure-02

  • INGREDIENTS AND APPEARANCE
    INATAL ULTRA 
    inatal ultra tablet, coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63044-154
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 2700 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg
    CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM - UNII:SY7Q814VUP) CALCIUM CITRATE 200 mg
    IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (IRON - UNII:E1UOL152H7) IRON PENTACARBONYL 90 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU]
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (ALPHA-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL ACETATE 30 [iU]
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE - UNII:X66NSO3N35) THIAMINE MONONITRATE 3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3.4 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 20 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12 ug
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM IODIDE 150 ug
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC - UNII:J41CSQ7QDS) ZINC OXIDE 25 mg
    CUPRIC OXIDE (UNII: V1XJQ704R4) (COPPER - UNII:789U1901C5) CUPRIC OXIDE 2 mg
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    VANILLIN (UNII: CHI530446X)  
    Product Characteristics
    Color WHITE (dye-free) Score 2 pieces
    Shape OVAL Size 10mm
    Flavor Imprint Code cpc43
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63044-154-63 10 in 1 BOX, UNIT-DOSE
    1 10 in 1 BLISTER PACK
    2 NDC:63044-154-01 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 06/20/2005
    Labeler - Nnodum Pharmaceuticals (960457273)