NuFera

Manufacturer
CarWin Pharmaceutical Associates, LLC
Effective date
2016-01-27
Label type
DIETARY SUPPLEMENT
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:29:16

Label at a glance#

ProductNuFera
Active ingredientASCORBIC ACID, CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE MAGNESIUM, FOLIC ACID, CYANOCOBALAMIN, IRON PENTACARBONYL
Label structure14 sections

Dosage and administration

One tablet daily with or without food or as prescribed by your healthcare provider.

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Supplement Facts
Serving Size: 1 TabletServings per container: 30
Amount per serving%DV*
Vitamin C (as ascorbic acid)170 mg283%
Vitamin D3 (as cholecalciferol)1000 IU250%
Vitamin B6 (as pyridoxine HCl)15 mg750%
Folate (630 mcg of L-methylfolate magnesium, molar equivalent to 600 mcg of L-methylfolic acid; and 400 mcg of folic acid)1 mg250%
Vitamin B12 (as cyanocobalamin)16 mcg267%
Iron (as carbonyl iron)125 mg694%

* Percent Daily Value

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

HEALTH CLAIM SECTION

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

CONTRAINDICATIONS

HEALTH CLAIM SECTION

NuFera™ is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindicated to iron therapy.

WARNINGS SECTION

WARNING: ACCIDENTAL OVERDOSE OF IRON-CONTAINING PRODUCTS IS A LEADING CAUSE OF FATAL POISONING IN CHILDREN UNDER 6 YEARS OF AGE.

PRECAUTIONS

PRECAUTIONS SECTION

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

PRECAUTIONS SECTION

General

HEALTH CLAIM SECTION

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

HEALTH CLAIM SECTION

Safety and effectiveness in pediatric population have not been established.

GERIATRIC USE

HEALTH CLAIM SECTION

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

ADVERSE REACTIONS

HEALTH CLAIM SECTION

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

HEALTH CLAIM SECTION

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

DOSAGE & ADMINISTRATION SECTION

One tablet daily with or without food or as prescribed by your healthcare provider.

HOW SUPPLIED

HEALTH CLAIM SECTION

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

HEALTH CLAIM SECTION

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.

SAFE HANDLING WARNING SECTION

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.

HEALTH CLAIM SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15370-265-30

NuFERA™
IRON SUPPLEMENT

125 mg CARBONYL IRON

Rx
30 Tablets

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

PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label
PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15370-265-30EA - Each15370-2658a59e038-d576-467e-9f9d-6d81e35ff70412016-02-04

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15370-26515370-265-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c5222dfd-a466-4b73-b103-c3ebf8f7777c8b7a7851-d0a4-4efc-a141-dcffeda8d1cf2015-12-22Boxed warning, Adverse reactionsExact identifier
spl set id: 8b7a7851-d0a4-4efc-a141-dcffeda8d1cf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.