DESCRIPTION
PreGenna is a prescription prenatal/postnatal multivitamin/multimineral dietary supplement.
| Supplement Facts | ||
|---|---|---|
| Serving Size: 1 Tablet | ||
| Amount per Serving | % Daily Value | |
| ** Daily Value not established. | ||
| Vitamin A (as Beta-Carotene) | 300 mcg RAE | 33% |
| Vitamin C (as Ascorbic Acid) | 60 mg | 67% |
| Vitamin D (as Cholecalciferol) | 10 mcg | 50% |
| Vitamin E (as dl-Alpha Tocopherol Acetate) | 4.5 mg (10 IU) | 33% |
| Vitamin B6 (as Pyridoxine HCl) | 26 mg | 1529% |
| Biotin | 0.280 mg | 933% |
| Folate | 1.67 mg DFE | 418% |
| (from Folic Acid) | 0.67 mg DFE | |
| (from 5-Methyl Tetrahydrofolate, Calcium Salt) | 1 mg DFE | |
| Vitamin B12 (as Cyanocobalamin) | 0.013 mg | 542% |
| Calcium (as Calcium Carbonate) | 80 mg | 6% |
| Magnesium (as Magnesium Oxide) | 25 mg | 6% |
| Ferrochel™ Iron (as Ferrous BisGlycinate Chelate) | 20 mg | 111% |
| Iodine (as Potassium Iodide) | 0.150 mg | 100% |
OTHER INGREDIENTS: Microcrystalline Cellulose, Maltodextrin, Croscarmellose Sodium, Silicon Dioxide, Stearic Acid, Magnesium Stearate, Film Coating (Hydroxypropyl Methylcellulose, Polyethylene Glycol, Titanium Dioxide, FD&C Blue # 1)
Allergen: NONE
INDICATIONS
PreGenna is a multivitamin/multimineral dietary supplement indicated for the use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactation on nonlactating mothers.
PreGenna can also be beneficial in improving the nutritional status of women prior to conception.
CONTRAINDICATIONS
PreGenna is contraindicated in patients with a known hypersensitivity to any of the ingredients.
PRECAUTIONS
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
| WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poising in children under 6. Keep this product out of the reach of children. In the case of accidental overdose, call a doctor or poison control center immediately. |
ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
DOSAGE AND ADMINISTRATION
Before, during and/or after pregnancy, one tablet daily or as directed by a physician.
HOW SUPPLIED
Bottles of 30 tablets (71741-072-301). Tablet is light blue, oblong.
This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels increased risk associated with masking B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner (64 FR 8760). 1-3 The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription. This is not an Orange Book product. This product may be administered only under a physician's supervision and all prescriptions using this product shall be pursuant to state statues as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.
- Federal Register Notice of August 2, 1973 (38 FR 20750)
- Federal Register Notice of October 17, 1980 (45 FR 69043, 69044)
- Federal Register Notice of March 5, 1996 (61 FR 8760)
- 1
- Redmont Pharmaceuticals does not represent this product code to be National Drug Code (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.
MADE IN USA
Distributed by:
Redmont Pharmaceuticals, LLC
Birmingham, AL 35209
800-986-5909
Ferrochel™ is a trademark of Albion Laboratories, Inc.
| These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. |
KEEP THIS AND ALL MEDICATIONS OF THE REACH OF CHILDREN.
