INATAL ADVANCE - inatal advance tablet, coated 
Nnodum Pharmaceuticals

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.

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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

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f48327a6-figure-02
INATAL ADVANCE 
inatal advance tablet, coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63044-153
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A2700 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM - UNII:SY7Q814VUP) CALCIUM CARBONATE200 mg
IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (IRON - UNII:E1UOL152H7) IRON PENTACARBONYL90 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (ALPHA-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL ACETATE30 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE - UNII:X66NSO3N35) THIAMINE MONONITRATE3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3.4 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE20 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC - UNII:J41CSQ7QDS) ZINC OXIDE25 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (COPPER - UNII:789U1901C5) CUPRIC OXIDE2 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM - UNII:I38ZP9992A) MAGNESIUM OXIDE30 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSPOVIDONE (UNII: 68401960MK)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ETHYL VANILLIN (UNII: YC9ST449YJ)  
Product Characteristics
ColorWHITE (dye-free) Score2 pieces
ShapeOVALSize5mm
FlavorImprint Code cpc2859
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63044-153-649 in 1 BOX, UNIT-DOSE
110 in 1 BLISTER PACK
2NDC:63044-153-0190 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/10/2005
Labeler - Nnodum Pharmaceuticals (960457273)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corporation057795122MANUFACTURE

Revised: 10/2009
Document Id: f48327a6-8aa3-41b4-bfa5-a1665174e5ef
Set id: 0674df74-3e12-4484-9ffd-3c73f982a727
Version: 4
Effective Time: 20091026
 
Nnodum Pharmaceuticals