{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Multitol-M Multivitamin, Folate HYPROMELLOSES POLYETHYLENE GLYCOL 400 .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- MAGNESIUM OXIDE MAGNESIUM CATION CHROMIUM NICOTINATE CHROMIC CATION COCOA CROSPOVIDONE STEARIC ACID MICROCRYSTALLINE CELLULOSE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE MOLYBDENUM MOLYBDENUM SELENIUM SELENIUM CROSCARMELLOSE SODIUM CHOLECALCIFEROL CHOLECALCIFEROL SILICON DIOXIDE MAGNESIUM STEARATE RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE ASCORBIC ACID ASCORBIC ACID LEVOMEFOLATE CALCIUM LEVOMEFOLIC ACID METHYLCOBALAMIN METHYLCOBALAMIN 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 Oblong Caplet" ], "description": [ "DESCRIPTION: Each caplet contains: Vitamin A (as Retinyl Acetate)………………........ 1500 mcg RAE Vitamin C (as Ascorbic Acid) .………………..………...… 120 mg Vitamin D3 (As Cholecalciferol) ..……………….. 20 mcg (800 IU) Vitamin E (DL-alpha Tocopheryl Acetate) .……………….. 13.5 mg Thiamin (As Thiamine Mononitrate) …….………………..… 3 mg Riboflavin …………………………….….…..………….... 3.4 mg Niacin (as Niacinamide)…………………………………… 20 mg Vitamin B6 (as Pyridoxine Hydrochloride)…………………. 20 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) …2040 mcg DFE (1200 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)………………………….. 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. Coating: (Hydroxypropyl Methylcellulose [HPMC], PEG-8)." ], "indications_and_usage": [ "INDICATIONS: Multitol-M ™ is indicated to provide vitamins and minerals supplement to men and women. Folate is effective in the treatment of megaloblastic anemias due to a deficiency of folate (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood." ], "contraindications": [ "CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients." ], "warnings": [ "WARNING: Administration of folate alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B 12 is deficient." ], "precautions": [ "PRECAUTIONS: Folate 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 folate to patients with undiagnosed anemia, since folate 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 B 12 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: Multitol-M ™ 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: Allergic sensitization has been reported following both oral and parenteral administration of folate. 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." ], "drug_interactions": [ "Drug Interactions: Multitol-M ™ 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": [ "Adverse Reactions: Allergic sensitization has been reported following both oral and parenteral administration of folate. 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." ], "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION: One (1) Multitol-M™ caplet daily, between meals or as directed by a physician. Do not administer to children under the age of 12." ], "how_supplied": [ "HOW SUPPLIED: Multitol-M™ are beige speckled, oblong, coated caplets in bottle containing 30 caplets (NDC 59088-005-54). Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure." ], "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]." ], "package_label_principal_display_panel": [ "Multitol-M TM Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873 Label" ], "set_id": "163fdc9e-a405-c3ee-e063-6294a90afd49", "id": "163fdc9e-a406-c3ee-e063-6294a90afd49", "effective_time": "20240417", "version": "1", "openfda": { "brand_name": [ "Multitol-M" ], "generic_name": [ "MULTIVITAMIN, FOLATE" ], "manufacturer_name": [ "PureTek Corporation" ], "product_ndc": [ "59088-005" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ ".ALPHA.-TOCOPHEROL ACETATE, DL-", "ASCORBIC ACID", "CALCIUM CARBONATE", "CHOLECALCIFEROL", "CHROMIUM NICOTINATE", "LEVOMEFOLATE CALCIUM", "MAGNESIUM OXIDE", "MANGANESE SULFATE", "METHYLCOBALAMIN", "MOLYBDENUM", "NIACINAMIDE", "PYRIDOXINE HYDROCHLORIDE", "RIBOFLAVIN", "SELENIUM", "THIAMINE MONONITRATE", "VITAMIN A ACETATE", "ZINC OXIDE" ], "spl_id": [ "163fdc9e-a406-c3ee-e063-6294a90afd49" ], "spl_set_id": [ "163fdc9e-a405-c3ee-e063-6294a90afd49" ], "package_ndc": [ "59088-005-54" ], "is_original_packager": [ true ], "nui": [ "N0000193618", "M0001797", "M0022797", "N0000175952" ], "pharm_class_epc": [ "Vitamin C [EPC]", "Vitamin D [EPC]" ], "pharm_class_cs": [ "Ascorbic Acid [CS]", "Vitamin D [CS]" ], "unii": [ "WR1WPI7EW8", "PQ6CK8PD0R", "H0G9379FGK", "1C6V77QF41", "A150AY412V", "A9R10K3F2F", "3A3U0GI71G", "W00LYS4T26", "BR1SN1JS2W", "81AH48963U", "25X51I8RD4", "68Y4CF58BV", "TLM2976OFR", "H6241UJ22B", "8K0I04919X", "3LE3D9D6OY", "SOI2LOH54Z" ] } } ] }