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.
Natafort
FDA Label NDC 0178-0716
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mission Pharmacal Company for the product Natafort (NDC 0178-0716). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, other, indications, contraindications, warning, precautions, adverse reactions, dosage and administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 |
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
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.
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.
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
Principal Display Panel (90 Tablet Bottle Label)
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