Label: IRON FOLATE PLUS capsule
- NHRIC Code(s): 69367-218-30, 69367-218-09
- Packager: Westminster Pharmaceuticals, LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated July 19, 2023
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- Official Label (Printer Friendly)
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STATEMENT OF IDENTITY
Supplement Facts Serving Size: 1 Capsule
Servings Per Container: 90Amount Per Serving % DV for Adults and Children over 12 - *
- Also containing Ascorbic Acid Precursors as (1) Acid Metabolites including, calcium ascorbate, magnesium ascorbate, potassium ascorbate, and sodium ascorbate; (2) Basic Amino Acids including lysine acetate; (3) Flavonoids including hesperidin complex; and (4) Glutathione.
Vitamin C (Ascorbic Acid)* 210 mg 233% Thiamin (as Thiamine Mononitrate) 5 mg 417% Riboflavin 5 mg 385% Niacin 20 mg NE 125% Vitamin B6 (as Pyridoxine HCI) 25 mg 1471% Folate 1667 mcg DFE (1000 mcg folic acid) 417% Vitamin B12 (as Cyanocobalamin) 10 mcg 417% Biotin 300 mcg 1000% Pantothenic Acid (as D-Calcium Pantothenate) 7 mg 140% Iron (from Ferrous Fumarate and Polysaccharide Iron Complex) 125 mg 694% Other Ingredients: Hydroxypropyl Methyl Cellulose, Microcrystalline Cellulose, Silicon Dioxide, Magnesium Stearate, Titanium Dioxide, FD&C Yellow #5
- HEALTH CLAIM
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CONTRAINDICATIONS
Iron Folate Plus is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.
- WARNINGS
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PRECAUTIONS
General
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia assessment, such that hematologic remission can occur while neurological manifestations remain progressive.
Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin.
- DRUG INTERACTIONS
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ADVERSE REACTIONS
Folic Acid
Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.
Ferrous Fumarate
Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, taking Iron Folate Plus after meals may diminish occasional G.I. disturbances. Iron Folate Plus is best absorbed when taken at bedtime.
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OVERDOSAGE
Acute overdosage of iron may cause abdominal pain, nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other more chronic symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300 mg/kg body weight. Toxic effects are seen at 10-20 mg/kg elemental iron. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Iron Folate Plus should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this product out of the reach of children.
- DESCRIPTION
- DIRECTIONS FOR USE
- HOW SUPPLIED
- STORAGE
- HEALTH CLAIM
- HEALTH CLAIM
- PRINCIPAL DISPLAY PANEL - 90 Capsule Bottle Label
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INGREDIENTS AND APPEARANCE
IRON FOLATE PLUS
iron folate plus capsuleProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:69367-218 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 62.5 mg IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 62.5 mg ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 210 mg THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 5 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 5 mg NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 20 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 25 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 10 ug BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 300 ug CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 7 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:69367-218-30 30 in 1 BOTTLE 2 NHRIC:69367-218-09 90 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 07/19/2023 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color scoring 1 shape size (solid drugs) 24 mm imprint Labeler - Westminster Pharmaceuticals, LLC (079516651)
