Group: Iron
Group: Calcium
Also known as: Ca Threonate
UNII Code: HBB4YPO93U
Group: Acacia
Also known as: Gum Arabic
Group: Calcium
Group: Iron
Also known as: Sumalate
Group: Ethyl Cellulose
UNII Code: 7Z8S9VYZ4B
Group: Iron
Also known as: elemental iron
Group: Vitamin B9 (Folate)
Folate, also known as Vitamin B9, is a water-soluble vitamin essential for DNA synthesis, cell growth, and the production of red blood cells. It is important for proper brain function and plays a crucial role in mental and emotional health. Folate is naturally found in a wide range of foods, including leafy green vegetables, fruits, nuts, beans, and dairy products. It is also available as a dietary supplement and is typically included in B-vitamin complexes.
Group: Fumed Silica
Group: Acacia
Also known as: Acacia
UNII Code: 5C5403N26O
Group: Hypromellose
Also known as: Hydroxypropylmethylcellulose, Hydroxypropyl Methyl Cellulose, Hydroxypropyl Methylcellulose, Hypromellose
Group: Hypromellose
Also known as: HF brand, Klucel(R) HXF, HPC
UNII Code: 9XZ8H6N6OH
Group: Cellulose
Microcrystalline cellulose (MCC) is a refined wood pulp that is commonly used as a texturizer, anti-caking agent, and bulking agent in food and dietary supplements. It is a white, odorless powder that is insoluble in water and is often used to improve the texture and stability of products.
Also known as: Cellulose, MCC
Group: Polyethylene glycol
Also known as: Polyethylene Glycol
Group: Polyethylene glycol
Also known as: PEG, Macrogol
UNII Code: 3WJQ0SDW1A
Group: Polysorbate
Group: Povidone
Group: Vitamin B6 (pyridoxine)
Pyridoxine, commonly known as Vitamin B6, is a water-soluble vitamin that plays a critical role in brain health, production of neurotransmitters, and the metabolism of proteins, fats, and carbohydrates. It is essential for the proper functioning of sugars, fats, and proteins in the body and is crucial for the development of the brain and nervous system.
Also known as: Vitamin B6
Group: Vitamin C (ascorbic acid)
Also known as: Vitamin C
Group: Color
Red 40, also known as Allura Red AC, is a synthetic azo dye derived from petroleum used extensively as a red food colorant. It is approved by the FDA for use in foods, beverages, cosmetics, and pharmaceuticals. It imparts a bright red hue and is commonly found in candies, soft drinks, baked goods, and other processed products.
Also known as: Allura Red AC, FD&C Red No. 40, E129, Red Dye #40, Allura Red
UNII Code: 2Z6R9D8D4B
Group: Iron
Also known as: elemental Iron
Group: Magnesium Silicate
Group: Potassium Citrate
UNII Code: 86R1NVR0HW
Group: vegetable oil
Group: Vitamin B12
UNII Code: 8406EY2OQA
Group: Folate
Vitamin B9, commonly known as folic acid or folate, is a B-vitamin essential for various bodily functions, including DNA synthesis and repair, cell division, and growth. It is particularly important during periods of rapid growth such as during pregnancy and fetal development. Folic acid is the synthetic form often used in supplements and fortified foods, while folate is the naturally occurring form found in certain foods.
Also known as: Folic Acid, Folate
UNII Code: 935E97BOY8
Group: Vitamin D
Vitamin D3, also known as cholecalciferol, is a fat-soluble vitamin that plays a crucial role in bone health by aiding in the absorption of calcium and phosphorus in the body. It can be produced endogenously when ultraviolet rays from sunlight strike the skin and trigger vitamin D synthesis. Additionally, Vitamin D3 is found in dietary supplements and fortified foods to help maintain adequate levels for optimal health.
Also known as: Vitamin D3
UNII Code: 1C6V77QF41
PRESCRIBING INFORMATION DESCRIPTION Red, oval bisected tablets embossed "VP042".
WARNINGS Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
Folic Acid Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia.
HOW SUPPLIED CORVITE(R) FE available in carton unit dose pack of 30 (6 child resistant blister cards of 5 tablets per card).
US Patent No. 5,516,925 US Patent No. 6,716,814 US Patent No. 7,838,042 US Patent No. 6,706,901 Other Patents Pending
ADVERSE REACTIONS Adverse reactions with iron therapy may include 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.
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, cyanossi, lassitude, seizures, shock and coma.
CLINICAL PHARMCOLOGY 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.
DOSAGE AND ADMINISTRATION Usual adult dose is 1 tablet daily, or as prescribed by a physician.
INDICATIONS AND USAGE CORVITE(R) FE is indicated for the prevention and treatment of iron deficiency anemia and/or nutritional megaloblastic anemias.
CONTRAINDICATIONS CORVITE(R) FE is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemochromatosis and hemosiderosis are contraindications to iron therapy.
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.
PRECAUTIONS General Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with CORVITE(R) FE. Since the anemia may be a result of a sytemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible.
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Geriatric Use Clinical studies on this product have not been performed in subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.
CFELB021101
STORAGE Store at controlled room temperature 15(0)-30(0)C (59(0)-86(0)F) [See USP]. Protect from light, moisture and excessive heat. Dispense in a tight, light resistant container as defined in the USP using a child-resistant closure.
KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.
Rx Only.
DimaCal and TRAACS are registered trademarks of Albion Laboratories, Inc. Malates covered by U.S. Patent 6,706,904, chelate covered by U.S. Patent 7,838,042; and patents pending.
Sumalate (ferrous asparto glycinate) is a trademark of Albion International, Inc., Clearfield, Utah.
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Brand: EST
550 g
UPC: 8 95524 00075 5
