INATAL ADVANCE tablet, coated

INATAL ADVANCE by

Drug Labeling and Warnings

INATAL ADVANCE by is a Prescription medication manufactured, distributed, or labeled by Nnodum Pharmaceuticals, Contract Pharmacal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

Rx Only

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

INGREDIENTS AND APPEARANCE

INATAL ADVANCE 
inatal advance tablet, coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 63044-153
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 CARBONATE (UNII: H0G9379FGK) (CALCIUM - UNII:SY7Q814VUP)	CALCIUM CARBONATE	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
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC - UNII:J41CSQ7QDS)	ZINC OXIDE	25 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (COPPER - UNII:789U1901C5)	CUPRIC OXIDE	2 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM - UNII:I38ZP9992A)	MAGNESIUM OXIDE	30 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (dye-free)	Score	2 pieces
Shape	OVAL	Size	5mm
Flavor		Imprint Code	cpc2859
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63044-153-64	9 in 1 BOX, UNIT-DOSE
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
Unapproved drug other		06/10/2005

Labeler - Nnodum Pharmaceuticals (960457273)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmacal Corporation		057795122	MANUFACTURE