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Multitol-M: Package Insert / Prescribing Info

Package insert / product label
Generic name: multivitamin, folate
Dosage form: tablet
Drug class: Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Apr 23, 2024.

Multitol-M 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 for Multitol-M

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

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Warnings

Administration of folate alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B 12 is deficient.

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.

Multitol-M 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 is Multitol-M 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

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].

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

MULTITOL-M
multivitamin, folate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59088-005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-13.5 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE200 mg
CHROMIUM NICOTINATE (UNII: A150AY412V) (CHROMIC CATION - UNII:X1N4508KF1) CHROMIUM NICOTINATE35 ug
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE20 mg
MOLYBDENUM (UNII: 81AH48963U) (MOLYBDENUM - UNII:81AH48963U) MOLYBDENUM45 ug
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM55 ug
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL20 ug
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3.4 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM2040 ug
METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN8 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A1500 ug
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 mg
MANGANESE SULFATE (UNII: W00LYS4T26) (MANGANESE CATION (2+) - UNII:H6EP7W5457) MANGANESE CATION (2+)2.3 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
COCOA (UNII: D9108TZ9KG)
CROSPOVIDONE (UNII: 2S7830E561)
STEARIC ACID (UNII: 4ELV7Z65AP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
Coloryellow (Beige speckled caplet) Scoreno score
ShapeCAPSULE (Oblong Caplet) Size19mm
FlavorImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-005-5430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/17/2024
Labeler - PureTek Corporation (785961046)

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