FDA Label for Nutralyn
View Indications, Usage & Precautions
Nutralyn Product Label
The following document was submitted to the FDA by the labeler of this product Oncora Pharma Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
Folaten is a prescription multivitamin/multimineral dietary supplement.
SUPPLEMENT FACTS | ||
Serving size Amount per serving: | 1 tablet % Daily Value | |
Vitamin A (as Beta-Carotene) | 300 mcg RAE | 33% |
Vitamin C (as Ascorbic Acid) | 60mg | 67% |
Vitamin D (as Cholecalciferol) | 10mcg | 50% |
Vitamin E (as di-Alpha Tocopherol Acetate) | 4.5 mg (10 IU) | 33% |
Vitamin 86 (as Pyrldoxine HCI) | 26mg | 1529% |
Biotin | 0.280mg | 933% |
Folate | 1.67 mg □FE | 418% |
(from Folic Acid) | 0.67 mg □FE | |
(from 5 Methyl Tetrahydrotolate Calcium Salt) | 1 mg DFE | |
Vitamin 812 (as Cyanocobalamin) | 0.013 mg | 542% |
Calcium (as Calcium Carbonate) | 80 mg | 6% |
Magnesium (as Magnesium Oxide) | 25mg | 6% |
Ferrochel"" | 20mg | 111mg |
Iodine (as Potassium Iodide) | 0.150mg | 100% |
| Other Ingredients: Microcrystalline Cellulose, Maltodextrin, Croscarmellose Sodium, Silcon Dioxide, Stearic Acid, Magnesium Stearate, FiIm Coating (Hydroxypropyl Methylcellulose, Polyethylene Glycol, Titanium Dioxide, FD&C Blue# 1 | ||
Indications And Usage
Folaten is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a subuoptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.
Contraindications
Folaten 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 B 12 deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Warnings
WARNING Accidental overdose of iron-containing products is a leading cause of fatal poising in children under 6. KEEP THIS PRODUCT OUT OF 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 reports adverse side effects or to obtain product information, contact Oncora Pharma at 888-321-2821.
Dosage And Administration
One tablet daily or as directed by a physician.
How Supplied
Bottles of 30 Tablets (85477-901-30). Tablet is tan, oblong.
Storage
STORAGE: Store at 20- 25 degree C (68-77 F) excersions permitted to 15-30 degree 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:
888-321-2821
Oncora Pharma
Dallas, TX 75161
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