Multitol-m

Multitol-m
SPL v1
SPL
SPL Set ID 163fdc9e-a405-c3ee-e063-6294a90afd49
Route
ORAL
Published
Effective Date 2021-10-21
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
.alpha.-tocopherol, Dl- (13.5 mg) Magnesium Cation (200 mg) Chromic Cation (35 ug) Pyridoxine (20 mg) Molybdenum (45 ug) Selenium (55 ug) Cholecalciferol (20 ug) Riboflavin (3.4 mg) Niacinamide (120 mg) Ascorbic Acid (2040 ug) Levomefolic Acid (8 ug) Methylcobalamin (1500 ug) Calcium Cation (3 mg) Vitamin A (25 mg) Zinc Cation (2.3 mg) Manganese Cation (2+)
Inactive Ingredients
Hypromelloses Polyethylene Glycol 400 Cocoa Crospovidone Stearic Acid Microcrystalline Cellulose Croscarmellose Sodium Silicon Dioxide Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Shape: capsule Color: yellow Size: 19 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-04-17

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).

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

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

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

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).

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.


Medication Information

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

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

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

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).

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.

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).

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].

Warning:

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

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.

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.

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.

Multitol M Tm

Manufactured in the USA by:

PureTek Corporation


Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

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.

Contraindications:

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

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).

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.


Structured Label Content

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].

Warning: (WARNING:)

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

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: (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.

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.

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.

Multitol M Tm (Multitol-M TM)

Manufactured in the USA by:

PureTek Corporation


Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

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.

Contraindications: (CONTRAINDICATIONS:)

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

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).

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.


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