KeyFolic: Package Insert and Label Information
KEYFOLIC- beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, pyridoxine hydrochloride, biotin, folic acid, levomefolate calcium, cyanocobalamin, calcium carbonate, magnesium oxide, ferrous bisglycinate and potassium iodide tablet
Redmont Pharmaceuticals, LLC
71741-353-30
Multivitamin Dietary Supplement
Dispensed by Prescription
DESCRIPTION
KeyFolic is a prescription multivitamin/multimineral dietary supplement.
| Supplement Facts | ||
|---|---|---|
| Serving size 1 Tablet | ||
| Amount per Serving: | %Daily Value | |
| ||
| 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
KeyFolic is a prescription multivitamin/multimineral dietary supplement formulated for the clinical dietary management of suboptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.
CONTRAINDICATIONS
KeyFolic 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.
You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact Redmont Pharmaceuticals, LLC at 1-800-986-5909.
DOSAGE AND ADMINISTRATION
One tablet daily or as directed by a physician.
HOW SUPPLIED
Bottles of 30 tablets (71741-353-301). Tablet is light blue, oblong.
- 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.
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)
STORAGE AND HANDLING
STORAGE
Store at 20°-25° C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Avoid excessive heat, light and moisture.
TAMPER EVIDENT
Do not use if seal is broken or missing.
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 OUT OF THE REACH OF CHILDREN
© 2023 Redmont Pharmaceuticals, LLC
353111-0223
PRINCIPAL DISPLAY PANEL — 30 Tablet Bottle Label
71741-353-30
KeyFolic
DIETARY SUPPLEMENT
30 TABLETS
Dispensed by Prescription
| KEYFOLIC beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, pyridoxine hydrochloride, biotin, folic acid, levomefolate calcium, cyanocobalamin, calcium carbonate, magnesium oxide, ferrous bisglycinate, and potassium iodide tablet | |||||||||||||||||||||||||||||||||||||||||||||
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| Labeler — Redmont Pharmaceuticals, LLC (080843607) |
Revised: 03/2023 Redmont Pharmaceuticals, LLC
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