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

NataFort by

Drug Labeling and Warnings

NataFort by is a Prescription medication manufactured, distributed, or labeled by Mission Pharmacal Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

• 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

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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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

Labeler - Mission Pharmacal Company (008117095)

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