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NuFera

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. For further information about unapproved drugs, click here.

Supplement Facts
Serving Size: 1 Tablet Servings per container: 30
Amount per serving %DV*
*
Percent Daily Value
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.

INDICATIONS

NuFera™ is a multivitamin and mineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.

Contraindications

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.

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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Precautions

General

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.

PEDIATRIC USE

Safety and effectiveness in pediatric population have not been established.

GERIATRIC USE

In general, dose selection in elderly population should be cautious and start at the lower end of the dosing range.

Adverse Reactions

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.

Overdosage

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.

DIRECTIONS

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).

STORAGE

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.

Manufactured for:
CarWin Pharmaceutical Associates, LLC
Slidell, LA 70461

MADE IN CANADA

Rx

CW-250-SB-02
Rev. 11/15

PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label

15370-265-30

NuFERA
IRON SUPPLEMENT

125 mg CARBONYL IRON

Rx
30 Tablets

See attached labeling for complete product information.
Rev. 11/2015

NuFera 
ascorbic acid, cholecalciferol, pyridoxine hydrochloride, levomefolate magnesium, folic acid, cyanocobalamin, and iron pentacarbonyl tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:15370-265
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 170 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 1000 [iU]
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 15 mg
LEVOMEFOLATE MAGNESIUM (LEVOMEFOLIC ACID) LEVOMEFOLIC ACID 600 ug
FOLIC ACID (FOLIC ACID) FOLIC ACID 400 ug
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 16 ug
IRON PENTACARBONYL (FERROUS CATION) FERROUS CATION 125 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
CALCIUM CARBONATE  
DOCUSATE SODIUM  
HYPROMELLOSES  
KERACYANIN  
POLYVINYL ALCOHOL  
TRIACETIN  
TALC  
TITANIUM DIOXIDE  
SILICON DIOXIDE  
CROSCARMELLOSE SODIUM  
HYDROXYPROPYL CELLULOSE (TYPE H)  
MAGNESIUM STEARATE  
STEARIC ACID  
Product Characteristics
Color RED Score 2 pieces
Shape OVAL Size 19mm
Flavor Imprint Code 265
Contains         
Packaging
# Item Code Package Description
1 NDC:15370-265-30 30 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 12/16/2015
Labeler - CarWin Pharmaceutical Associates, LLC (079217215)
Revised: 12/2015
 
CarWin Pharmaceutical Associates, LLC
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