INATAL ADVANCE description, usages, side effects, indications, overdosage, supplying and lots more!

INATAL ADVANCE

Nnodum Pharmaceuticals

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
INATAL ADVANCE Tablet 63044-153-64



FULL PRESCRIBING INFORMATION

Prenatal multivitamin/multimineral tablet
combining 15 vitamins and minerals,
including calcium and carbonyl iron.

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 controll center immediately.

INATAL Advanced ® is a white, dye-free, oval shaped, oil-and-water soluble multivitamin/multimineral tablet which contains calcium carbonate and carbonyl iron.

Each tablet contains:

Vitamin A (as beta-carotene) . . . . . . . . . . . 2700 I.U.

Vitamin C (ascorbic acid) . . . . . . . . . . . . . . 120 mg

Calcium (as calcium carbonate) . . . . . . . . . . 200 mg

Elemental Iron (as carbonyl iron) . . . . . . . . . . 90 mg

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

Vitamin E (dl-alpha tocopheryl acetate) . . . . . 30 I.U.

Vitamin B1 (as thiamine mononitrate) . . . . . . . . 3 mg

Vitamin B2 (riboflavin, USP) . . . . . . . . . . . . . 3.4 mg

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

Vitamin B6 (as pyridoxine HCI, USP) . . . . . . . 20 mg

Folic Acid, USP . . . . . . . . . . . . . . . . . . . . . . . 1 mg

Vitamin B12 (cyanocobalamin) . . . . . . . . . . . 12 mcg

Zinc (as zinc oxide, USP) . . . . . . . . . . . . . . . . 25 mg

Copper (as cupric oxide) . . . . . . . . . . . . . . . . . 2 mg

Magnesium (as magnesium oxide, USP) . . . . . 30 mg

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

INACTIVE INGREDIENTS: Carnauba wax, crospovidone, ethyl vanillin, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, silicon dioxide, stearic acid, and titanium dioxide

INATAL ADVANCE ® 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. INATAL Advanced® can also be beneficial in improving the nutritional status of women prior to conception.

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

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.

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

Safety and effectiveness in pediatric patients have not been established

.

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 staring 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.

One tablet daily or as directed by a physician.

NDC 63044-153-64 Unit Dose Packs of 90’s with each blister card 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 Pharmaceuticals
Cincinnati, Ohio 45229

INATAL ADVANCE

INATAL ADVANCE TABLET, COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:63044-153
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
VITAMIN A 2700 [iU]
ASCORBIC ACID ASCORBIC ACID 120 mg
CALCIUM CARBONATE 200 mg
IRON PENTACARBONYL FERROUS CATION 90 mg
CHOLECALCIFEROL CHOLECALCIFEROL 400 [iU]
ALPHA-TOCOPHEROL ACETATE ALPHA-TOCOPHEROL 30 [iU]
THIAMINE MONONITRATE THIAMINE ION 3 mg
RIBOFLAVIN RIBOFLAVIN 3.4 mg
NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 20 mg
FOLIC ACID FOLIC ACID 1 mg
Cyanocobalamin CYANOCOBALAMIN 12 ug
Zinc Oxide Zinc oxide 25 mg
CUPRIC OXIDE CUPRIC CATION 2 mg
magnesium oxide 30 mg
DOCUSATE SODIUM DOCUSATE 50 mg

Inactive Ingredients

Ingredient Name Strength
carnauba wax
CROSPOVIDONE
hydroxypropyl cellulose
MAGNESIUM STEARATE
propylene glycol
SILICON DIOXIDE
STEARIC ACID
titanium dioxide
ETHYL VANILLIN

Product Characteristics

Color Size Imprint Code Shape
WHITE (dye-free) 5 mm cpc2859 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 NDC:63044-153-01 90 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2005-06-10


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