MULTITOL-M- multivitamin, folate tablet

Multitol-M by

Drug Labeling and Warnings

Multitol-M by is a Prescription medication manufactured, distributed, or labeled by PureTek Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

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.

WARNING:

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.

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:

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

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

INGREDIENTS AND APPEARANCE

MULTITOL-M 
multivitamin, folate tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 59088-005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
.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 OXIDE	200 mg
CHROMIUM NICOTINATE (UNII: A150AY412V) (CHROMIC CATION - UNII:X1N4508KF1)	CHROMIUM NICOTINATE	35 ug
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	20 mg
MOLYBDENUM (UNII: 81AH48963U) (MOLYBDENUM - UNII:81AH48963U)	MOLYBDENUM	45 ug
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B)	SELENIUM	55 ug
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	20 ug
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3.4 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	120 mg
LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)	LEVOMEFOLATE CALCIUM	2040 ug
METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W)	METHYLCOBALAMIN	8 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	200 mg
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	1500 ug
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	3 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	25 mg
MANGANESE SULFATE (UNII: W00LYS4T26) (MANGANESE CATION (2+) - UNII:H6EP7W5457)	MANGANESE CATION (2+)	2.3 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	yellow (Beige speckled caplet)	Score	no score
Shape	CAPSULE (Oblong Caplet)	Size	19mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59088-005-54	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/17/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/17/2024

Labeler - PureTek Corporation (785961046)