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NataFort Tablets

Generic Name: ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin and iron
Dosage Form: tablet

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.

NataFort®
PRENATAL MULTIVITAMIN TABLET WITH IRON

NataFort Tablets 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.

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.

NataFort Tablets Dosage and Administration

One tablet daily or as directed by a physician.

Store at controlled room temperature.

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

How is NataFort Tablets Supplied

Bottles of 90 tablets each - NDC 0178-0716-90.

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

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 LABEL Item Code (Source) NDC:0178-0716
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ascorbic acid (Ascorbic acid) Ascorbic acid 120 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol 400 [iU]
.alpha.-tocopherol acetate, dl- (.alpha.-tocopherol acetate, dl-) .alpha.-tocopherol acetate, dl- 11 [iU]
Thiamine mononitrate (Thiamine) Thiamine mononitrate 2 mg
Riboflavin (Riboflavin) Riboflavin 3 mg
Niacinamide (Niacinamide) Niacinamide 20 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 10 mg
Folic Acid (Folic Acid) Folic Acid 1 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 12 ug
Iron (Iron) Iron 60 mg
Inactive Ingredients
Ingredient Name Strength
polyethylene glycols  
calcium carbonate  
povidone  
cellulose, microcrystalline  
croscarmellose sodium  
titanium dioxide  
magnesium silicate  
vitamin a palmitate  
magnesium stearate  
ethyl vanillin  
Dimethylaminoethyl methacrylate - butyl methacrylate - methyl methacrylate copolymer  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 14mm
Flavor Imprint Code N1
Contains         
Packaging
# Item Code Package Description
1 NDC:0178-0716-90 90 TABLET (TABLET) 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 Operations
Mission Pharmacal Company 927726893 MANUFACTURE
Revised: 08/2011
 
Mission Pharmacal Company
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