Multitol-M
Multivitamin, Folate · Tablet · Oral
Uses
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.
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.
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.
Side effects
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).
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).
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
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].
Label text from the FDA structured product label by PureTek Corporation (revised Apr 17, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- .alpha.-tocopherol Acetate, Dl- in 1 product
- Magnesium Oxide in 1 product
- Chromium Nicotinate in 1 product
- Pyridoxine Hydrochloride in 1 product
- Molybdenum in 1 product
- Selenium in 1 product
- Cholecalciferol in 1 product
- Riboflavin in 1 product
- Niacinamide in 1 product
- Ascorbic Acid in 1 product
- Levomefolate Calcium in 1 product
- Methylcobalamin in 1 product
Multitol-M NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 59088-005 | .alpha.-tocopherol Acetate, Dl- 13.5 mg/1; Magnesium Oxide 200 mg/1; Chromium Nicotinate 35 ug/1; Pyridoxine… Tablet | PureTek Corporation | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is Multitol-M used for?
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.
What are the side effects of Multitol-M?
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. See the full label for the complete list.
Who makes Multitol-M?
Multitol-M is listed by 1 labeler in the FDA NDC directory, including PureTek Corporation.