NUFERA- ascorbic acid, cholecalciferol, pyridoxine hydrochloride, levomefolate magnesium, folic acid, cyanocobalamin, and iron pentacarbonyl tablet

NuFera by

Drug Labeling and Warnings

NuFera by is a Other medication manufactured, distributed, or labeled by CarWin Pharmaceutical Associates, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

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.

WARNINGS

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 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.

SAFE HANDLING WARNING

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

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

INGREDIENTS AND APPEARANCE

NUFERA 
ascorbic acid, cholecalciferol, pyridoxine hydrochloride, levomefolate magnesium, folic acid, cyanocobalamin, and iron pentacarbonyl tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:15370-265
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	170 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	1000 [iU]
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	15 mg
LEVOMEFOLATE MAGNESIUM (UNII: 1VZZ62R081) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)	LEVOMEFOLIC ACID	600 ug
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	400 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	16 ug
IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	125 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
CALCIUM CARBONATE (UNII: H0G9379FGK)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
HYPROMELLOSES (UNII: 3NXW29V3WO)
KERACYANIN (UNII: V0N2VMB4FV)
POLYVINYL ALCOHOL (UNII: 532B59J990)
TRIACETIN (UNII: XHX3C3X673)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:15370-265-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Dietary Supplement		12/16/2015

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	2
shape
size (solid drugs)	19 mm
imprint

Labeler - CarWin Pharmaceutical Associates, LLC (079217215)