Monday, October 3, 2016

Inatal Advance



prenatal multivitamin / multimineral

Dosage Form: tablet, coated
Inatal Advance Tablet

63044-153-64

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.

DESCRIPTION


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



INDICATIONS:


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.



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



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 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.



DOSAGE AND ADMINISTRATION:


One tablet daily or as directed by a physician.



HOW SUPPLIED:


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



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL











Inatal Advance 
Inatal Advance  tablet, coated










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)63044-153
Route of AdministrationORALDEA Schedule    





















































Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VITAMIN A (VITAMIN A)VITAMIN A2700 [iU]
ASCORBIC ACID (ASCORBIC ACID)ASCORBIC ACID120 mg
CALCIUM CARBONATE (CALCIUM)CALCIUM CARBONATE200 mg
IRON PENTACARBONYL (IRON)IRON PENTACARBONYL90 mg
CHOLECALCIFEROL (CHOLECALCIFEROL)CHOLECALCIFEROL400 [iU]
ALPHA-TOCOPHEROL ACETATE (ALPHA-TOCOPHEROL)ALPHA-TOCOPHEROL ACETATE30 [iU]
THIAMINE MONONITRATE (THIAMINE)THIAMINE MONONITRATE3 mg
RIBOFLAVIN (RIBOFLAVIN)RIBOFLAVIN3.4 mg
NIACINAMIDE (NIACINAMIDE)NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE)PYRIDOXINE HYDROCHLORIDE20 mg
FOLIC ACID (FOLIC ACID)FOLIC ACID1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN)CYANOCOBALAMIN12 ug
ZINC OXIDE (ZINC)ZINC OXIDE25 mg
CUPRIC OXIDE (COPPER)CUPRIC OXIDE2 mg
MAGNESIUM OXIDE (MAGNESIUM)MAGNESIUM OXIDE30 mg
DOCUSATE SODIUM (DOCUSATE)DOCUSATE SODIUM50 mg






















Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CROSPOVIDONE 
HYDROXYPROPYL CELLULOSE 
MAGNESIUM STEARATE 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
STEARIC ACID 
TITANIUM DIOXIDE 
ETHYL VANILLIN 


















Product Characteristics
ColorWHITE (dye-free)Score2 pieces
ShapeOVALSize5mm
FlavorImprint Codecpc2859
Contains      


















Packaging
#NDCPackage DescriptionMultilevel Packaging
163044-153-649 BLISTER PACK In 1 BOX, UNIT-DOSEcontains a BLISTER PACK
110 TABLET In 1 BLISTER PACKThis package is contained within the BOX, UNIT-DOSE (63044-153-64)
263044-153-0190 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/10/2005


Labeler - Nnodum Pharmaceuticals (960457273)









Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corporation057795122MANUFACTURE
Revised: 10/2009Nnodum Pharmaceuticals




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