Label: IRON FOLATE-F capsule
- NHRIC Code(s): 69367-217-30, 69367-217-09
- 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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STATEMENT OF IDENTITY
Supplement Facts Serving Size: 1 Capsule Servings Per Container: 90 Amount Per Serving % DV for Adults and Children over 12 % DV for Pregnant and Lactating Women - *
- Also containing Ascorbic Acid Precursors as (1) Acid Metabolites including niacinamide ascorbate, 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)* 40 mg 44% 33% Niacin (as Niacinamide Ascorbate) 3 mg NE 19% 17% Folate 1667 mcg DFE
(1000 mcg folic acid)417% 278% Iron (from Ferrous Fumarate and Polysaccharide Iron Complex) 125 mg 694% 463% Other Ingredients: Hydroxypropyl Methyl Cellulose, Microcrystalline Cellulose, Silicon Dioxide, Magnesium Stearate, Titanium Dioxide, FD&C Red #40, FD&C Blue #1
Iron Folate-F is a professionally prescribed iron, folic acid, and vitamin supplement used to improve the nutritional status of patients with iron and/or folate deficiency anemia, including women in the prenatal and postnatal period. Do not administer to children under the age of 12.
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CONTRAINDICATIONS
Iron Folate-F is contraindicated in patients with a known hypersensitivity to any of the ingredients, also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindicated, 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. Anemia requires appropriate investigation to determine its cause or causes. Periodic clinical and laboratory studies are considered essential. Blood tests including hemoglobin and hematocrit should be done to determine the adequacy of therapy. Folic acid should be used with care in the presence of peptic ulcer disease, regional enteritis, and ulcerative colitis. In doses above 0.1 mg daily, folic acid may obscure the diagnosis of pernicious anemia.
USAGE IN PREGNANCY
Before Iron Folate-F is prescribed for megaloblastic anemia in pregnancy, appropriate diagnostic exclusion of Addisonian pernicious anemia (due to faulty or blocked absorption of vitamin B12, or extrinsic factor or either a genetic, immunological or surgical basis) should be carried out.
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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, heartburn, and vomiting) occur occasionally, but are usually mild and may subside with continuation of therapy. Reducing the dose and administering it with meals will minimize these effects in the sensitive patient. Iron may turn stools black. This is a harmless effect that is a result of unabsorbed iron. Although the absorption of iron is best when taken between meals, giving Iron Folate-F after meals may diminish occasional G.I. disturbances. Iron Folate-F 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-F should be stored beyond the reach of children to prevent against accidental iron poisoning.
- DESCRIPTION
- DIRECTIONS FOR USE
- HOW SUPPLIED
- STORAGE
- HEALTH CLAIM
- PRINCIPAL DISPLAY PANEL - 90 Capsule Bottle Label
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INGREDIENTS AND APPEARANCE
IRON FOLATE-F
iron folate-f capsuleProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:69367-217 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 FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 40 mg NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 3 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 RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:69367-217-30 30 in 1 BOTTLE 2 NHRIC:69367-217-09 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) 22 mm imprint Labeler - Westminster Pharmaceuticals, LLC (079516651)
