71741-327-30
Multivitamin
Dietary Supplement
Dispensed by Prescription1
- 1
- 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 statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.
| Supplement Facts | ||
|---|---|---|
| Serving Size: 1 Softgel | ||
| Serving Per Container: | ||
| Amount Per Serving | % Daily Value | |
|
||
| Calories | 5 | |
| Total Fat | 0.5 g | <1% |
| Cholesterol | 25 mg | 8% |
| Vitamin A (50% Beta-Carotene, 50% Retinyl Palmitate) | 1200 mcg RAE (4000 IU) | 133% |
| Vitamin C (as Ascorbic Acid) | 60 mg | 67% |
| Vitamin D (as Cholecalciferol) | 10 mcg | 50% |
| Vitamin E (as d-Alpha Tocopherol) | 20.1 mg (30 IU) | 134% |
| Thiamin (B1) (from Thiamine Mononitrate) | 1.7 mg | 142% |
| Riboflavin (B2) | 2 mg | 154% |
| Niacin (as Niacinamide) | 20 mg | 125% |
| Vitamin B6 (from Pyridoxine Hydrochloride) | 2.5 mg | 147% |
| Folate (1000 mcg Folic Acid) | 1700 mcg DFE | 425% |
| Vitamin B12 (as Cyanocobalamin) | 8 mcg | 333% |
| Biotin | 300 mcg | 1000% |
| Pantothenic Acid (from d-Calcium Pantothenate) | 10 mg | 200% |
| Calcium (from Calcium Carbonate) | 200 mg | 15% |
| Iron (from Carbonyl Iron) | 28 mg | 156% |
| Iodine (from Potassium Iodide) | 150 mcg | 100% |
| Magnesium (from Magnesium Oxide) | 50 mg | 12% |
| Zinc (from Zinc Oxide) | 15 mg | 136% |
| Cooper (Cooper Oxide) | 2 mg | 222% |
| Eicosapentaenoic Acid (as EE) (from Fish Oil) | 200 mg | * |
| Docosahexaenoic Acid (as EE) (from Fish Oil) | 35 mg | * |
Other Ingredients: Bovine Gelatin, Glycerin, Yellow Beeswax, Purified Water, Soy Lecithin, Annatto.
Allergens: Fish (Anchovy, Sardine, Tuna), Soy.
Does Not Contain: Peanuts, Tree Nuts, Shellfish, Eggs, Milk, Wheat.
INDICATIONS
FolaGent DHA is prescription dietary supplement formulated for the clinical dietary management of suboptimal nutritional status in patients where advanced folate supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health.
FolaGent DHA is formulated as a prescription dietary supplement for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.
CONTRAINDICATIONS
This product 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: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding. |
| WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In 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
Usual adult dose is 1 softgel taken orally once daily or as prescribed by a licensed medical practitioner.
HOW SUPPLIED
Child-resistant bottles of 30 softgels (71741-327-302). Softgel is oblong shaped and orange reddish in color with possible dark spots.
- 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)
- 2
- 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.
Distributed by:
Redmont Pharmaceuticals, LLC
Birmingham, AL 35209
800-986-5909
| 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.
© 2022 Redmont Pharmaceuticals, LLC
327111-0422
