Label: VITREXATE FE- ferrous fumarate, folic acid tablet
- NDC Code(s): 59088-168-54
- Packager: PureTek Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated January 11, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
DESCRIPTION:
Each caplet contains:
Vitamin A (as retinyl acetate)………………………….. 1500 mcg
Vitamin C (as ascorbic acid)……………………………… 120 mg
Vitamin D3 (as cholecalciferol)…………………………… 20 mcg
Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg
Thiamine (as thiamine mononitrate)………………………… 3 mg
Riboflavin (vitamin B2)……………………………………. 3.4 mg
Niacin (as niacinamide)…………………………………… 20 mg
Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg
Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid)
Vitamin B12 (as cyanocobalamin)………………………….. 8 mcg
Calcium (as calcium carbonate)…………………………. 200 mg
Iron (as ferrous fumarate)………………………………… 27 mg
Magnesium (as magnesium oxide)……………………… 200 mg
Zinc (as zinc oxide)……………………………………….. 25 mg
Selenium (as selinium amino acid chelate)………………. 55 mcg
Manganese (as manganese sulfate)……………………… 2.3 mg
Chromium (as chromium polynicotinate)……………….. 35 mcg
Molybdenum (as molybdenum amino acid chelate)……… 45 mcgOther Ingredients:
organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid, Clear Coating: (hydroxypropyl methylcellulose, PEG-8). -
INDICATIONS:
Vitrexate FE is indicated for the treatment of iron deficiency anemia
and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive
blood loss and advanced age.Also for the treatment of a condition in which iron deficiency and
vitamin C deficiency occur together, along with a deficient intake or increased need for
B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in
convalescence. -
CONTRAINDICATIONS:
This product 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. -
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.
Administration of folic acid alone is improper therapy for pernicious anemia and other
megaloblastic anemias in which vitamin B12 is deficient.Precaustion Section
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic
remission can occur while neurological manifestations remain progressive.
There is a potential danger in administering folic acid to patients with undiagnosed anemia,
since folic acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic
manifestations of the disease while allowing the neurologic complications to progress. This mayresult in severe nervous system damage before the correct diagnosis is made. Adequate doses
of vitamin B12 may prevent, halt, or improve the neurologic changes caused by pernicious
anemia.
The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements
should be considered.For use on the order of a healthcare practitioner.
Call your doctor about side effects. To report side effects, call PureTek Corporation at
1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Drug Interactions:
Vitrexate FE 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 or 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, giving Vitrexyl + Iron after meals
may control occasional gastrointestinal disturbances. Vitrexyl + Iron is best absorbed when
taken at bedtime.
Adverse reactions have been reported with specific vitamins and minerals but generally at levels
substantially higher than those contained herein. However, allergic and idiosyncratic reactions
are possible at lower levels. Iron, even at the usual recommended levels, has been associated
with gastrointestinal intolerance in some patients. -
OVERDOSE:
Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and
vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include
pallor and cyanosis, melena, shock, drowsiness, and coma. The estimated overdose of orally
ingested iron is 300 mg/kg body weight. When overdoses are ingested by children, severe
reactions, including fatalities, have resulted. Vitrexate FE should be stored beyond the
reach of children to prevent accidental iron poisoning. Keep this and all other drugs
out of reach of children. - DOSAGE AND ADMINISTRATION:
-
HOW SUPPLIED:
Vitrexate FE are beige speckled, oblong, coated caplets, bottles containing 30 caplets – NDC 59088-168-54. Dispense in a tight, light-resistant
container as defined in the USP/NF with a child-resistant closure.
Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP]. Protect from light
and moisture and avoid excessive heat. -
STORAGE:
Do not use if bottle seal is broken.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP].
Protect from light and moisture and avoid excessive heat.
To report a serious adverse event or to obtain product information, contact 877-921-7873. - Vitrexate FE
-
INGREDIENTS AND APPEARANCE
VITREXATE FE
ferrous fumarate, folic acid tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59088-168 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHROMIUM NICOTINATE (UNII: A150AY412V) (CHROMIC CATION - UNII:X1N4508KF1) CHROMIUM NICOTINATE 35 ug FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1000 ug VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 1500 ug RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3.4 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 20 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 8 ug CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 200 mg ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 3 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 25 mg MANGANESE SULFATE (UNII: W00LYS4T26) (MANGANESE CATION (2+) - UNII:H6EP7W5457) MANGANESE CATION (2+) 2.3 mg FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 27 mg MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 200 mg MOLYBDENUM (UNII: 81AH48963U) (MOLYBDENUM - UNII:81AH48963U) MOLYBDENUM 45 ug .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 30 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 20 ug SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM 55 ug Inactive Ingredients Ingredient Name Strength STEARIC ACID (UNII: 4ELV7Z65AP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1) COCOA (UNII: D9108TZ9KG) CROSPOVIDONE (UNII: 2S7830E561) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color brown (BEIGE SPECKLED CAPLET) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59088-168-54 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/30/2020 Labeler - PureTek Corporation (785961046) Establishment Name Address ID/FEI Business Operations PureTek Corporation 785961046 manufacture(59088-168) , pack(59088-168) , label(59088-168)
