Vitrexate & Vitranol

Vitrexate & Vitranol
SPL v10
SPL
SPL Set ID b34fee43-bea9-45b7-e053-2a95a90aad4d
Route
ORAL
Published
Effective Date 2021-02-24
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyridoxine (20 mg) Selenium (55 ug) Folic Acid (1000 ug) Magnesium Cation (200 mg) Molybdenum (45 ug) Cyanocobalamin (3 mg) Vitamin A (8 ug) Chromic Cation (1500 ug) Cholecalciferol (35 ug) Riboflavin (20 ug) Niacinamide (3.4 mg) .alpha.-tocopherol, Dl- (30 mg) Zinc Cation (25 mg) Calcium Cation (120 mg) Ascorbic Acid (2.3 mg) Manganese Cation (2+)
Inactive Ingredients
Polyethylene Glycol 400 Hydroxymethyl Cellulose Magnesium Stearate Cocoa Crospovidone Microcrystalline Cellulose Croscarmellose Sodium Stearic Acid Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Shape: capsule Color: brown Size: 19 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2020-11-30

Description

Each caplet contains: Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamine (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 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 Clear Coating: (hydroxypropyl methylcellulose, PEG-8).

Dosage and Administration

One (1) caplet daily, between meals or as directed by a physician. Do not administer to children under the age of 12.

Contraindications

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 folic acid. 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. Iron, even at the usually recommended levels, has been associated with gastrointestinal intolerance in some patients.

Drug Interactions

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

Vitrexate TM and Vitranol TM are beige speckled, oblong, coated caplets, bottles containing 30 caplets – NDC 59088-167-54 NDC 59088-171-54 Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. Store at controlled room temperature 20º-25ºC (68º-77ºF). [See USP]. Protect from light and moisture and avoid excessive heat.


Medication Information

Dosage and Administration

One (1) caplet daily, between meals or as directed by a physician. Do not administer to children under the age of 12.

Contraindications

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 folic acid. 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. Iron, even at the usually recommended levels, has been associated with gastrointestinal intolerance in some patients.

Drug Interactions

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

Vitrexate TM and Vitranol TM are beige speckled, oblong, coated caplets, bottles containing 30 caplets – NDC 59088-167-54 NDC 59088-171-54 Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. Store at controlled room temperature 20º-25ºC (68º-77ºF). [See USP]. Protect from light and moisture and avoid excessive heat.

Description

Each caplet contains: Vitamin A (as retinyl acetate)………………………….. 1500 mcg Vitamin C (as ascorbic acid)……………………………… 120 mg Vitamin D3 (as cholecalciferol)…………………………… 20 mcg Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg Thiamine (as thiamine mononitrate)………………………… 3 mg Riboflavin (vitamin B2)……………………………………. 3.4 mg Niacin (as niacinamide)…………………………………… 20 mg Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid) Vitamin B12 (as cyanocobalamin)………………………….. 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 Clear Coating: (hydroxypropyl methylcellulose, 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].

Protect from light and moisture and avoid excessive heat.

To report a serious adverse event or to obtain product information, contact

1-877-921-7873.

Warning:

Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.

Vitranol Tm

Description:

Each caplet contains:

Vitamin A (as retinyl acetate)………………………….. 1500 mcg

Vitamin C (as ascorbic acid)……………………………… 120 mg

Vitamin D3 (as cholecalciferol)…………………………… 20 mcg

Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg

Thiamine (as thiamine mononitrate)………………………… 3 mg

Riboflavin (vitamin B2)……………………………………. 3.4 mg

Niacin (as niacinamide)…………………………………… 20 mg

Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg

Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid)

Vitamin B12 (as cyanocobalamin)………………………….. 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 Clear Coating: (hydroxypropyl methylcellulose, PEG-8).

Indications:

To provide vitamin supplements to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.

Precautions:

Folic acid 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 folic acid to patients with undiagnosed anemia, since folic acid 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 B12 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.

Vitrexate Tm

Manufactured in the USA by:

PureTek Corporation

Panorama City, CA 91402

Questions? Call toll-free:

1-877-921-7873

How Supplied:

Vitrexate TM and Vitranol TM are beige speckled, oblong, coated caplets, bottles containing 30 caplets –

NDC 59088-167-54

NDC 59088-171-54

Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

Store at controlled room temperature 20º-25ºC (68º-77ºF). [See USP]. Protect from light and moisture and avoid excessive heat.

Adverse Reactions:

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. 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. Iron, even at the usually recommended levels, has been associated with gastrointestinal intolerance in some patients.

Contraindications:

Contraindicated in patients with a known hypersensitivity to any of the ingredients.

Drug Interactions:

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) 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].

Protect from light and moisture and avoid excessive heat.

To report a serious adverse event or to obtain product information, contact

1-877-921-7873.

Warning: (WARNING:)

Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.

Vitranol Tm (Vitranol TM)

Description: (DESCRIPTION:)

Each caplet contains:

Vitamin A (as retinyl acetate)………………………….. 1500 mcg

Vitamin C (as ascorbic acid)……………………………… 120 mg

Vitamin D3 (as cholecalciferol)…………………………… 20 mcg

Vitamin E (dl-alpha tocopheryl acetate)…………………… 30 mg

Thiamine (as thiamine mononitrate)………………………… 3 mg

Riboflavin (vitamin B2)……………………………………. 3.4 mg

Niacin (as niacinamide)…………………………………… 20 mg

Vitamin B6 (as pyridoxine hydrochloride)…………………. 20 mg

Folate (as folic acid)……….. 1700 mcg DFE (1000 mcg folic acid)

Vitamin B12 (as cyanocobalamin)………………………….. 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 Clear Coating: (hydroxypropyl methylcellulose, PEG-8).

Indications: (INDICATIONS:)

To provide vitamin supplements to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.

Precautions: (PRECAUTIONS:)

Folic acid 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 folic acid to patients with undiagnosed anemia, since folic acid 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 B12 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.

Vitrexate Tm (Vitrexate TM)

Manufactured in the USA by:

PureTek Corporation

Panorama City, CA 91402

Questions? Call toll-free:

1-877-921-7873

How Supplied: (HOW SUPPLIED:)

Vitrexate TM and Vitranol TM are beige speckled, oblong, coated caplets, bottles containing 30 caplets –

NDC 59088-167-54

NDC 59088-171-54

Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

Store at controlled room temperature 20º-25ºC (68º-77ºF). [See USP]. Protect from light and moisture and avoid excessive heat.

Adverse Reactions:

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. 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. Iron, even at the usually recommended levels, has been associated with gastrointestinal intolerance in some patients.

Contraindications: (CONTRAINDICATIONS:)

Contraindicated in patients with a known hypersensitivity to any of the ingredients.

Drug Interactions:

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) caplet daily, between meals or as directed by a physician. Do not administer to children under the age of 12.


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