Drug Facts
Composition & Profile
Identifiers & Packaging
How Supplied: Dexatran™ are transparent capsules in bottles containing 30 capsules – NDC 59088-643-54. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Do not use if bottle seal is broken. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at controlled room temperature 20o to 25oC (68o to 77oF). [See USP]. Protect from light and moisture and avoid excessive heat.; Dexatran™ Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 Questions? Call toll-free: 1-877-921-7873 Label
- How Supplied: Dexatran™ are transparent capsules in bottles containing 30 capsules – NDC 59088-643-54. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Do not use if bottle seal is broken. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at controlled room temperature 20o to 25oC (68o to 77oF). [See USP]. Protect from light and moisture and avoid excessive heat.
- Dexatran™ Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 Questions? Call toll-free: 1-877-921-7873 Label
Overview
Active ingredients: Each capsule contains: Vitamin C (as sodium ascorbate).................................200 mg Thiamin (as thiamine mononitrate)............................... 10 mg Riboflavin....................................................................... 6 mg Niacin (as niacinamide)................................................ 30 mg Vitamin B6 (as pyridoxine hydrochloride)....................... 5 mg Folate (as folic acid)...... 1667 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin).............................. 15 mcg Pantothenic Acid (as d-calcium pantothenate)............. 10 mg Iron (as ferrous fumarate)............................................ 18 mg Magnesium (as magnesium sulfate)............................ 6.9 mg Zinc (as zinc sulfate).................................................. 18.2 mg Copper (as cupric sulfate)........................................... 0.8 mg Manganese (as manganese sulfate)............................ 1.3 mg Other Ingredients: Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Silicon Dioxide, Vegetable Capsule.
Indications & Usage
: Dexatran™ is indicated to provide dietary management for men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.
Dosage & Administration
: Adults (persons over 12 years of age) one (1) Dexatran™ capsule daily, between meals or as directed by a physician. Do not administer to children under the age of 12.
Warnings & Precautions
Warnings: 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.
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.
Adverse Reactions
Folic Acid: Allergic sensitizations has 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 Dexatran™ after meals may control occasional gastrointestinal disturbances. Dexatran™ 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.
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