NUFERA- ascorbic acid, cholecalciferol, pyridoxine hydrochloride, levomefolate magnesium, folic acid, cyanocobalamin, and iron pentacarbonyl tablet CarWin Pharmaceutical Associates, LLC ------NuFera™ IRON SUPPLEMENT
Supplement Facts Servings per Serving Size: 1 Tablet 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- 1 mg 250% methylfolic acid; and 400 mcg of folic acid) Vitamin B12 (as cyanocobalamin) 16 mcg 267% Iron (as carbonyl iron) 125 mg 694% * 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 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 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 T ype DIETARY SUPPLEMENT Ite m Code (Source ) NHRIC:15370 -26 5 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCO RBIC ACID (UNII: PQ6 CK8 PD0 R) (ASCORBIC ACID - UNII:PQ6 CK8 PD0 R) ASCORBIC ACID 170 mg CHO LECALCIFERO L (UNII: 1C6 V77QF41) (CHOLECALCIFEROL - UNII:1C6 V77QF41) CHOLECALCIFEROL 10 0 0 [iU] PYRIDO XINE HYDRO CHLO RIDE (UNII: 6 8 Y4CF58 BV) (PYRIDOXINE - UNII:KV2JZ1BI6 Z) PYRIDOXINE 15 mg LEVO MEFO LATE MAGNESIUM (UNII: 1VZZ6 2R0 8 1) (LEVOMEFOLIC ACID - LEVOMEFOLIC 6 0 0 ug UNII:8 S9 5DH25XC) ACID FO LIC ACID (UNII: 9 35E9 7BOY8 ) (FOLIC ACID - UNII:9 35E9 7BOY8 ) FOLIC ACID 40 0 ug CYANO CO BALAMIN (UNII: P6 YC3EG20 4) (CYANOCOBALAMIN - UNII:P6 YC3EG20 4) CYANOCOBALAMIN 16 ug IRO N PENTACARBO NYL (UNII: 6 WQ6 2TAQ6 Z) (FERROUS CATION - UNII:GW8 9 58 1OWR) FERROUS CATION 125 mg
Inactive Ingredients Ingredient Name Strength CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U) STARCH, CO RN (UNII: O8 232NY3SJ) CALCIUM CARBO NATE (UNII: H0 G9 379 FGK) DO CUSATE SO DIUM (UNII: F0 5Q2T2JA0 ) HYPRO MELLO SES (UNII: 3NXW29 V3WO) KERACYANIN (UNII: V0 N2VMB4FV) PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 ) TRIACETIN (UNII: XHX3C3X6 73) TALC (UNII: 7SEV7J4R1U) TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4) CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 ) HYDRO XYPRO PYL CELLULO SE (TYPE H) (UNII: RFW2ET6 71P) MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 ) STEARIC ACID (UNII: 4ELV7Z6 5AP)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:15370 -26 5-30 30 in 1 BOTTLE
Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date Dietary Supplement 12/16 /20 15
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)
Revised: 1/2016 CarWin Pharmaceutical Associates, LLC