| Supplement Facts | ||
|---|---|---|
| Serving Size: 1 Capsule Servings Per Container: 90 |
||
| Amount Per Serving | % DV for Adults and Children over 12 | |
|
||
| 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
Iron Folate Plus is a prescription multivitamin nutritional supplement indicated for improving nutritional status in adults with certainty illnesses or vitamin deficiencies. DO NOT ADMINISTER TO CHILDREN UNDER THE AGE OF 12.
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
| WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately. |
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
Iron Folate Plus is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g. Aspirin, Heparin, Clopidogrel).
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.
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.
DIRECTIONS FOR USE
Adults and children over 12 years of age: One (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage.
HOW SUPPLIED
Iron Folate Plus is dispensed in child-resistant bottles of 90 Capsules (69367-218-09) and 30 Capsules (69367-218-30).
STORAGE
Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].
