Complete SPL Sections#
DESCRIPTION:
DESCRIPTION SECTION
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 Thiamin (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 mcg Other Ingredients: BHT, dicalcium phosphate, organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, modified food starch, pork gelatin, starch aluminium octenyl succinate, sodium ascorbate, sodium aluminum silicate, silicon dioxide, stearic acid, sucrose, Clear Coating: (hydroxypropyl methylcellulose, PEG-8).
INDICATIONS:
INDICATIONS & USAGE SECTION
Vitrexyl + Iron 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 treatment of condition in which iron deficiency and vitamin C deficiency occur together, alongwith a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well ascases of metabolic stress, and in convalescence.
CONTRAINDICATIONS:
CONTRAINDICATIONS SECTION
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:
WARNINGS SECTION
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.
OVERDOSE:
OVERDOSAGE SECTION
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. VitrexylTM + Iron should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of reach of children.
DOSAGE AND ADMINISTRATION:
DOSAGE & ADMINISTRATION SECTION
Adults (persons over 12 years of age) One (1) VitrexylTM + Iron caplet daily, between meals or as directed by a physician. Do not administer to children under the age of 12.
HOW SUPPLIED:
HOW SUPPLIED SECTION
Vitrexyl + Iron are yellow to brown speckled, oblong, coated caplets with "PT A17" debossed horizontally on one side, bottles containing 30 caplets – NDC 59088-165-54. 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:
STORAGE AND HANDLING SECTION
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.
Vitrexyl + Iron
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 Questions? Call toll-free: 1-877-921-7873 List No: 16554 JPA Rev: 36959
