DailyMed - NATAFORT- ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, and iron tablet

Contains inactivated NDC Code(s)
NDC Code(s): 0178-0716-90
Packager: Mission Pharmacal Company

Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: unapproved drug other

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 August 10, 2011

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DESCRIPTION

NataFort® is a prescription prenatal/postnatal multivitamin/mineral supplement. The tablet is white, coated, and oval in shape, and is debossed "N1" on one side and is blank on the other.

Each prenatal tablet contains:
Vitamin C (Ascorbic acid)	120 mg
Vitamin D3 (Cholecalciferol)	400 IU
Vitamin E (dl-alpha tocoperyl acetate)	11 IU
Thiamin (Vitamin B1)	2 mg
Riboflavin (Vitamin B2)	3 mg
Niacinamide (Vitamin B3)	20 mg
Vitamin B6 (Pyridoxine HCl)	10 mg
Folic Acid	1 mg
Vitamin B12 (Cyanocobalamin)	12 mcg
Iron (Ferrous fumarate, carbonyl iron)	60 mg

INDICATIONS

NataFort® is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.
CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
BOXED WARNING (What is this?)

WARNING

Accidental overdose of iron-containing products 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.
WARNING

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
PRECAUTIONS

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

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
DOSAGE AND ADMINISTRATION

One tablet daily or as directed by a physician.
STORAGE AND HANDLING

Store at controlled room temperature.

NOTICE: Contact with moisture can discolor or erode the tablet.
HOW SUPPLIED

Bottles of 90 tablets each - NDC 0178-0716-90.
SPL UNCLASSIFIED SECTION

US Patent 6,521,247

MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355

Copyright © 2011 Mission Pharmacal Company.

All rights reserved.

L071690 C01 Rev 005110
PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

NDC 0178-0716-90

NataFort®
PRENATAL MULTIVITAMIN TABLET WITH IRON
For use before, during and after pregnancy

90 Tablets

Rx Only

Mission®
PHARMACAL

US Patent 6,521,247

INGREDIENTS AND APPEARANCE

NATAFORT
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, and iron tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0178-0716
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Ascorbic acid (UNII: PQ6CK8PD0R) (Ascorbic acid - UNII:PQ6CK8PD0R)	Ascorbic acid	120 mg
Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41)	Cholecalciferol	400 [iU]
.alpha.-tocopherol acetate, dl- (UNII: WR1WPI7EW8) (.alpha.-tocopherol acetate, dl- - UNII:WR1WPI7EW8)	.alpha.-tocopherol acetate, dl-	11 [iU]
Thiamine mononitrate (UNII: 8K0I04919X) (Thiamine - UNII:X66NSO3N35)	Thiamine mononitrate	2 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR)	Riboflavin	3 mg
Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4)	Niacinamide	20 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z)	Pyridoxine Hydrochloride	10 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8)	Folic Acid	1 mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204)	Cyanocobalamin	12 ug
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7)	Iron	60 mg

Ingredient Name	Strength
Inactive Ingredients
polyethylene glycols (UNII: 3WJQ0SDW1A)
calcium carbonate (UNII: H0G9379FGK)
povidone (UNII: FZ989GH94E)
cellulose, microcrystalline (UNII: OP1R32D61U)
croscarmellose sodium (UNII: M28OL1HH48)
titanium dioxide (UNII: 15FIX9V2JP)
magnesium silicate (UNII: 9B9691B2N9)
vitamin a palmitate (UNII: 1D1K0N0VVC)
magnesium stearate (UNII: 70097M6I30)
ethyl vanillin (UNII: YC9ST449YJ)
Dimethylaminoethyl methacrylate - butyl methacrylate - methyl methacrylate copolymer (UNII: 905HNO1SIH)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	N1
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0178-0716-90	90 in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved drug other		08/25/2011

Labeler - Mission Pharmacal Company (008117095)

Name	Address	ID/FEI	Business Operations
Establishment
Mission Pharmacal Company		927726893	MANUFACTURE

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Published Date (What is this?)	Version	Files
Sep 1, 2011	1 (current)	download

	RxCUI	RxNorm NAME	RxTTY
1	1304497	alpha-tocopherol acetate 11 UNT / ascorbic acid 120 MG / cholecalciferol 400 UNT / folic acid 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / pyridoxine hydrochloride 10 MG / riboflavin 3 MG / thiamine mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet	SCD
2	1304497	alpha-tocopherol acetate 11 UNT / vitamin C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vitamin B6 hydrochloride 10 MG / riboflavin 3 MG / vitamin B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet	SY
3	1304497	alpha-tocopherol acetate 11 UNT / vitamin C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vitamin B6 hydrochloride 10 MG / riboflavin 3 MG / vit-B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet	SY
4	1304497	alpha-tocopherol acetate 11 UNT / vitamin C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vit-B6 hydrochloride 10 MG / riboflavin 3 MG / vitamin B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet	SY
5	1304497	alpha-tocopherol acetate 11 UNT / vitamin C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vit-B6 hydrochloride 10 MG / riboflavin 3 MG / vit-B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet	SY
6	1304497	alpha-tocopherol acetate 11 UNT / vit-C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vitamin B6 hydrochloride 10 MG / riboflavin 3 MG / vitamin B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet	SY
7	1304497	alpha-tocopherol acetate 11 UNT / vit-C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vitamin B6 hydrochloride 10 MG / riboflavin 3 MG / vit-B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet	SY
8	1304497	alpha-tocopherol acetate 11 UNT / vit-C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vit-B6 hydrochloride 10 MG / riboflavin 3 MG / vitamin B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet	SY
9	1304497	alpha-tocopherol acetate 11 UNT / vit-C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vit-B6 hydrochloride 10 MG / riboflavin 3 MG / vit-B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet	SY
10	1304503	alpha-tocopherol acetate 11 UNT / ascorbic acid 120 MG / cholecalciferol 400 UNT / folic acid 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / pyridoxine hydrochloride 10 MG / riboflavin 3 MG / thiamine mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet [Natafort]	SBD
11	1304503	alpha-tocopherol acetate 11 UNT / vitamin C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vitamin B6 hydrochloride 10 MG / riboflavin 3 MG / vitamin B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet [Natafort]	SY
12	1304503	alpha-tocopherol acetate 11 UNT / vitamin C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vitamin B6 hydrochloride 10 MG / riboflavin 3 MG / vit-B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet [Natafort]	SY
13	1304503	alpha-tocopherol acetate 11 UNT / vitamin C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vit-B6 hydrochloride 10 MG / riboflavin 3 MG / vitamin B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet [Natafort]	SY
14	1304503	alpha-tocopherol acetate 11 UNT / vitamin C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vit-B6 hydrochloride 10 MG / riboflavin 3 MG / vit-B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet [Natafort]	SY
15	1304503	alpha-tocopherol acetate 11 UNT / vit-C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vitamin B6 hydrochloride 10 MG / riboflavin 3 MG / vitamin B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet [Natafort]	SY
16	1304503	alpha-tocopherol acetate 11 UNT / vit-C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vitamin B6 hydrochloride 10 MG / riboflavin 3 MG / vit-B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet [Natafort]	SY
17	1304503	alpha-tocopherol acetate 11 UNT / vit-C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vit-B6 hydrochloride 10 MG / riboflavin 3 MG / vitamin B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet [Natafort]	SY
18	1304503	alpha-tocopherol acetate 11 UNT / vit-C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vit-B6 hydrochloride 10 MG / riboflavin 3 MG / vit-B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet [Natafort]	SY
19	1304503	NataFort (alpha-tocopherol acetate 11 UNT / ascorbic acid 120 MG / cholecalciferol 400 UNT / cyanocobalamin 12 MCG / folic acid 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / pyridoxine hydrochloride 10 MG / riboflavin 3 MG / thiamine mononitrate 2 MG) Oral Tablet	SY

RxCUI

RxNorm NAME

RxTTY

1304497

alpha-tocopherol acetate 11 UNT / ascorbic acid 120 MG / cholecalciferol 400 UNT / folic acid 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / pyridoxine hydrochloride 10 MG / riboflavin 3 MG / thiamine mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet

SCD

1304497

alpha-tocopherol acetate 11 UNT / vitamin C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vitamin B6 hydrochloride 10 MG / riboflavin 3 MG / vitamin B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet

1304497

alpha-tocopherol acetate 11 UNT / vitamin C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vitamin B6 hydrochloride 10 MG / riboflavin 3 MG / vit-B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet

1304497

alpha-tocopherol acetate 11 UNT / vitamin C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vit-B6 hydrochloride 10 MG / riboflavin 3 MG / vitamin B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet

1304497

alpha-tocopherol acetate 11 UNT / vitamin C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vit-B6 hydrochloride 10 MG / riboflavin 3 MG / vit-B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet

1304497

alpha-tocopherol acetate 11 UNT / vit-C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vitamin B6 hydrochloride 10 MG / riboflavin 3 MG / vitamin B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet

1304497

alpha-tocopherol acetate 11 UNT / vit-C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vitamin B6 hydrochloride 10 MG / riboflavin 3 MG / vit-B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet

1304497

alpha-tocopherol acetate 11 UNT / vit-C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vit-B6 hydrochloride 10 MG / riboflavin 3 MG / vitamin B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet

1304497

alpha-tocopherol acetate 11 UNT / vit-C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vit-B6 hydrochloride 10 MG / riboflavin 3 MG / vit-B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet

1304503

SBD

1304503

alpha-tocopherol acetate 11 UNT / vitamin C 120 MG / cholecalciferol 400 UNT / folate 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / vitamin B6 hydrochloride 10 MG / riboflavin 3 MG / vit-B1 mononitrate 2 MG / vitamin B12 0.012 MG Oral Tablet [Natafort]

1304503

NataFort (alpha-tocopherol acetate 11 UNT / ascorbic acid 120 MG / cholecalciferol 400 UNT / cyanocobalamin 12 MCG / folic acid 1 MG / iron carbonyl 60 MG / niacinamide 20 MG / pyridoxine hydrochloride 10 MG / riboflavin 3 MG / thiamine mononitrate 2 MG) Oral Tablet

Label: NATAFORT- ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, and iron tablet

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Label: NATAFORT- ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, and iron tablet

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WARNING

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NATAFORT- ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, and iron tablet

Number of versions: 1

NATAFORT- ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, and iron tablet

NATAFORT- ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, and iron tablet

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NATAFORT- ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, and iron tablet

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.