{"adverse_reactions":["Adverse Reactions: Allergic sensitization has been reported following both oral and parenteral administration of folic acid. 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 usually recommended levels, has been associated with gastrointestinal intolerance in some patients."],"contraindications":["CONTRAINDICATIONS: Contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["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 Magnesium (as magnesium oxide)……………………… 200 mg Zinc (as zinc oxide)……………………………………….. 25 mg Selenium (as selenium 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: organic cocoa powder, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid Clear Coating: (hydroxypropyl methylcellulose, PEG-8)."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: One (1) caplet daily, between meals or as directed by a physician. Do not administer to children under the age of 12."],"drug_interactions":["Drug Interactions: 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)."],"effective_time":"20230111","how_supplied":["HOW SUPPLIED: Vitrexate TM and Vitranol TM are beige speckled, oblong, coated caplets, bottles containing 30 caplets – NDC 59088-167-54 NDC 59088-171-54 Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. Store at controlled room temperature 20º-25ºC (68º-77ºF). [See USP]. Protect from light and moisture and avoid excessive heat."],"id":"f204b4b3-176f-8839-e053-2a95a90a7115","indications_and_usage":["INDICATIONS: To provide vitamin supplements to 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."],"openfda":{"brand_name":["Vitrexate","Vitranol"],"generic_name":["FOLIC ACID"],"is_original_packager":[true],"manufacturer_name":["PureTek Corporation"],"nui":["N0000193618","M0001797","M0022797","N0000175952","M0022794","N0000175951"],"package_ndc":["59088-171-54","59088-167-54"],"pharm_class_cs":["Ascorbic Acid [CS]","Vitamin D [CS]","Vitamin B 12 [CS]"],"pharm_class_epc":["Vitamin C [EPC]","Vitamin D [EPC]","Vitamin B12 [EPC]"],"product_ndc":["59088-167","59088-171"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"spl_id":["f204b4b3-176f-8839-e053-2a95a90a7115"],"spl_set_id":["b34fee43-bea9-45b7-e053-2a95a90aad4d"],"substance_name":[".ALPHA.-TOCOPHEROL ACETATE, DL-","MAGNESIUM OXIDE","CHROMIUM NICOTINATE","PYRIDOXINE HYDROCHLORIDE","MOLYBDENUM","SELENIUM","CHOLECALCIFEROL","RIBOFLAVIN","NIACINAMIDE","ASCORBIC ACID","FOLIC ACID","CYANOCOBALAMIN","CALCIUM CARBONATE","VITAMIN A ACETATE","THIAMINE MONONITRATE","ZINC OXIDE","MANGANESE SULFATE"],"unii":["935E97BOY8","3A3U0GI71G","68Y4CF58BV","A150AY412V","TLM2976OFR","SOI2LOH54Z","H0G9379FGK","PQ6CK8PD0R","WR1WPI7EW8","1C6V77QF41","W00LYS4T26","P6YC3EG204","3LE3D9D6OY","25X51I8RD4","H6241UJ22B","8K0I04919X","81AH48963U"],"upc":["0359088167540","0359088171547"]},"package_label_principal_display_panel":["Vitrexate TM Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 Questions? Call toll-free: 1-877-921-7873 Label","Vitranol TM Vitranol"],"precautions":["PRECAUTIONS: 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 may result 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: 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: Allergic sensitization has been reported following both oral and parenteral administration of folic acid. 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 usually recommended levels, has been associated with gastrointestinal intolerance in some patients."],"set_id":"b34fee43-bea9-45b7-e053-2a95a90aad4d","spl_product_data_elements":["Vitranol Folic Acid PYRIDOXINE HYDROCHLORIDE PYRIDOXINE SELENIUM SELENIUM FOLIC ACID FOLIC ACID MAGNESIUM OXIDE MAGNESIUM CATION MOLYBDENUM MOLYBDENUM THIAMINE MONONITRATE THIAMINE ION THIAMINE CYANOCOBALAMIN CYANOCOBALAMIN VITAMIN A ACETATE VITAMIN A POLYETHYLENE GLYCOL 400 HYDROXYMETHYL CELLULOSE MAGNESIUM STEARATE CHROMIUM NICOTINATE CHROMIC CATION CHOLECALCIFEROL CHOLECALCIFEROL RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE COCOA CROSPOVIDONE MICROCRYSTALLINE CELLULOSE .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- ZINC OXIDE ZINC CATION CALCIUM CARBONATE CALCIUM CATION CROSCARMELLOSE SODIUM STEARIC ACID SILICON DIOXIDE ASCORBIC ACID ASCORBIC ACID MANGANESE SULFATE MANGANESE CATION (2+) Beige Speckled Caplet Vitrexate Folic Acid POLYETHYLENE GLYCOL 400 HYDROXYMETHYL CELLULOSE COCOA CROSCARMELLOSE SODIUM CROSPOVIDONE STEARIC ACID MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE MAGNESIUM STEARATE .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- MAGNESIUM OXIDE MAGNESIUM CATION CHROMIUM NICOTINATE CHROMIC CATION PYRIDOXINE HYDROCHLORIDE PYRIDOXINE MOLYBDENUM MOLYBDENUM SELENIUM SELENIUM CHOLECALCIFEROL CHOLECALCIFEROL RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE ASCORBIC ACID ASCORBIC ACID FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM CARBONATE CALCIUM CATION VITAMIN A ACETATE VITAMIN A THIAMINE MONONITRATE THIAMINE ION THIAMINE ZINC OXIDE ZINC CATION MANGANESE SULFATE MANGANESE CATION (2+) Beige speckled caplet"],"storage_and_handling":["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 20º-25ºC (68º-77ºF). [See USP]. Protect from light and moisture and avoid excessive heat. To report a serious adverse event or to obtain product information, contact 1-877-921-7873."],"version":"10","warnings":["WARNING: Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient."]}