Generic Name: iron vitamin supplement
Dosage Form: tablet
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.
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|Serving Size: 1 Tablet||Servings per container: 30|
|Amount per serving||%DV*|
|Vitamin C (as ascorbic acid)||170 mg||283%|
|Vitamin D3 (as cholecalciferol)||1000 IU||250%|
|Vitamin B6 (as pyridoxine HCl)||15 mg||750%|
|Folate (630 mcg of L-methylfolate magnesium, molar equivalent to 600 mcg of L-methylfolic acid; and 400 mcg of folic acid)||1 mg||250%|
|Vitamin B12 (as cyanocobalamin)||16 mcg||267%|
|Iron (as carbonyl iron)||125 mg||694%|
INACTIVE INGREDIENTS: Microcrystalline Cellulose, Pregelatinized Starch, Calcium Carbonate, Docusate Sodium, Red Coating (Hydroxypropyl Methylcellulose, Anthocyanin Extract Powder, Polyvinyl Alcohol, Triacetin, TALC, Titanium Dioxide), Silicon Dioxide, Croscarmellose Sodium, Hydroxypropyl Cellulose, Magnesium Stearate, Stearic Acid, Fumed Silica.
NuFera™ is a multivitamin and mineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.
NuFera™ is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindicated to iron therapy.
WARNING: ACCIDENTAL OVERDOSE OF IRON-CONTAINING PRODUCTS IS A LEADING CAUSE OF FATAL POISONING IN CHILDREN UNDER 6 YEARS OF AGE.
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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with NuFera™. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible.
Safety and effectiveness in pediatric population have not been established.
In general, dose selection in elderly population should be cautious and start at the lower end of the dosing range.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient.
Carbonyl iron based products may decrease the absorption of medicines. Talk to your doctor or pharmacist before taking carbonyl products.
You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact CarWin Pharmaceutical Associates, LLC at 1-985-288-5122.
The clinical course of acute iron overdosage can be variable. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhea, tarry stools melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma.
One tablet daily with or without food or as prescribed by your healthcare provider.
How is NuFera Supplied
NuFera™ is available as red oblong tablets with imprint "265" in child-resistant bottles containing 30 tablets (15370-265-30) and in a 3ct professional sample (15370-265-03).
Store at 20°-25°C (68°-77°F); excursions permitted to at 15°-30°C (59°-86°F) [see USP]. Protect from light and moisture and avoid excessive heat. Dispense in a tight, light resistant container as defined by the USP using a child-resistant closure.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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.
TAMPER EVIDENT: Do not use if seal is broken or missing.
CarWin Pharmaceutical Associates, LLC
Slidell, LA 70461
MADE IN CANADA
PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label
125 mg CARBONYL IRON
See attached labeling for complete product information.
ascorbic acid, cholecalciferol, pyridoxine hydrochloride, levomefolate magnesium, folic acid, cyanocobalamin, and iron pentacarbonyl tablet
|Labeler - CarWin Pharmaceutical Associates, LLC (079217215)|
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- Drug class: iron products