Label: INATAL ULTRA tablet, coated
-
Contains inactivated NDC Code(s)
NDC Code(s): 63044-154-01, 63044-154-63 - Packager: Nnodum Pharmaceuticals
- Category: HUMAN PRESCRIPTION DRUG LABEL
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated October 26, 2009
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
SPL UNCLASSIFIED SECTION
Prenatal Multivitamin/
Multimineral Tablets
63044-154-63Rx 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:
- WARNINGS:
- PRECAUTIONS:
-
ADVERSE REACTIONS:
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
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:
- HOW SUPPLIED:
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
INATAL ULTRA
inatal ultra tablet, coatedProduct 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)
