ACTIVE INGREDIENTS
| Supplement Facts | ||
|---|---|---|
| Serving size: 1 Tablet | ||
| Each Tablet Contains: | %Daily Value | |
| Vitamin A (as Beta-Carotene) | 300 mcg RAE | 33% |
| Vitamin C (as Ascorbic Acid) | 100 mg | 111% |
| Vitamin D3 (as Cholecalciferol) | 24 mcg | 120% |
| Vitamin E (as dl-Alpha Tocopherol Acetate) | 4.5 mg (10 IU) | 30% |
| Thiamin | 1.5 mg | 125% |
| Riboflavin | 1.5 mg | 125% |
| Vitamin B6 (as Pyridoxine HCl) | 30 mg | 1764% |
| 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) | 13 mcg | 542% |
OTHER INGREDIENTS: Modified Cellulose, Croscarmellose Sodium, Stearic Acid, Silicon Dioxide, Magnesium Stearate, Titanium Dioxide, Polyethylene Glycol.
Preservative Free and Gluten Free. No sugar, starch, artificial colors, artificial flavors, wheat, yeast or corn added.
INDICATIONS
AvoWise is a prescription multivitamin that provides significant amounts of Vitamins B6, B12, C, D3, E, riboflavin, niacinamide, thiamine mononitrate, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop.
CONTRAINDICATIONS
AvoWise is contraindicated in patients with a known hypersensitivity to any the contained ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a licensed medical practitioner.
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. AvoWise should only be used under the direction and supervision of a licensed medical practitioner.
ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You may report side effects by calling Redmont Pharmaceuticals, LLC at 1-800- 986-5909.
HOW SUPPLIED
Bottles of 30 tablets (71741-474- 301). Tablet is white, round.
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, indications or claims of this product are not to be construed to be drug claims.
- Federal Register Notice of August 2, 1973
(38 FR20750) - Federal Register Notice of October 17, 1980
(45 FR69043, 69044) - Federal Register Notice of March 5, 1996
(61FR 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.
STORAGE AND HANDLING
STORAGE: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Avoid excessive heat, light and moisture.
