NDC | 15370-265-30 |
Set ID | 8b7a7851-d0a4-4efc-a141-dcffeda8d1cf |
Category | DIETARY SUPPLEMENT |
Packager | CarWin Pharmaceutical Associates, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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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
- CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
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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.
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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.
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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
- HOW SUPPLIED
- STORAGE
- SAFE HANDLING WARNING
- HEALTH CLAIM
- PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label
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INGREDIENTS AND APPEARANCE
NUFERA
ascorbic acid, cholecalciferol, pyridoxine hydrochloride, levomefolate magnesium, folic acid, cyanocobalamin, and iron pentacarbonyl tabletProduct 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)