| Supplement Facts | ||
|---|---|---|
| Serving Size: 1 Tablet | Servings per container: 30 | |
| Amount Per Serving: | % Daily Value | |
| Vitamin A (as beta-carotene) | 2100 IU | 42% |
| Vitamin C (as ascorbic acid) | 160 mg | 267% |
| Vitamin D3 (as cholecalciferol) | 400 IU | 100% |
| Vitamin E (as dl-alpha-tocopheryl acetate) | 40 IU | 133% |
| Thiamin (Vitamin B1 as thiamin HCl) | 4 mg | 267% |
| Riboflavin (Vitamin B2) | 4 mg | 235% |
| Niacin (as niacinamide) | 20 mg | 100% |
| Vitamin B6 (as pyridoxine HCl) | 20 mg | 1000% |
| Folate (as folic acid) | 1250 mcg | 313% |
| Vitamin B12 (as cyanocobalamin) | 30 mcg | 500% |
| Iron (as carbonyl iron) | 75 mg | 417% |
| Magnesium (as magnesium oxide) | 30 mg | 8% |
| Zinc (as zinc oxide) | 20 mg | 133% |
| Copper (as cupric oxide) | 1 mg | 50% |
OTHER INGREDIENTS
Coating (FD&C Blue#2 Lake, FD&C Red#40 Lake, FD&C Yellow#6 Lake, hydroxypropyl methylcellulose, polyvinyl alcohol, talc, titanium dioxide, triacetin), croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silica, silicon dioxide, and stearic acid.
CLINICAL PHARMACOLOGY
Iron is an essential component in the formation of hemoglobin. Adequate amounts of iron are necessary for effective erythropoiesis. Iron also serves as a cofactor of several essential enzymes, including cytochromes that are involved in electron transport. Folic acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is converted in the liver and plasma to its metabolically active form, tetrahydrofolic acid, by dihydrofolate reductase. Vitamin B12 is required for the maintenance of normal erythropoiesis, nucleoprotein and myelin synthesis, cell reproduction and normal growth. Intrinsic factor, a glycoprotein secreted by the gastric mucosa, is required for active absorption of vitamin B12 from the gastrointestinal tract.
INDICATIONS AND USAGE
ACTIVE FE™ is an oral prescription multi-vitamin/multi-mineral dietary supplement for the use in improving the nutritional status of patients with iron deficiency. 1
- 1
- This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent disease.
CONTRAINDICATIONS
ACTIVE FE™ is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemolytic anemia, hemochromatosis and hemosiderosis are contraindications to iron therapy.
WARNINGS
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
| WARNING Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately. |
Call your doctor about side effects. You may report side effects by calling Allegis Pharmaceuticals, LLC at 1-866-633-9033.
PRECAUTIONS
General
Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with ACTIVE FE™. 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.
ADVERSE REACTIONS
Adverse reactions with iron therapy may include GI irritations, constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Carbonyl iron based products may decrease the absorption of medicines. Talk to your doctor and pharmacist before taking carbonyl products if you take any prescription or over-the-counter medicines.
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.
HOW SUPPLIED
ACTIVE FE™ is supplied as red capsule shaped tablets with imprint FE1 in child-resistant bottles containing 30 tablets. (28595-433-302)
- 2
- This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency (pernicious anemia). Based on our assessment of the risk of obscuring pernicious anemia, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) – or similarly-formatted product code, as required by pedigree reporting requirements and supply-chain control as well as – in some cases, for insurance-reimbursement applications.All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician's supervision. There are no implied or explicit claims on therapeutic equivalence.
STORAGE
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container.
KEEP OUT OF REACH OF CHILDREN.
