Diatrol

Diatrol
SPL v2
SPL
SPL Set ID 0fe2b1cf-9085-ea65-e063-6294a90a80a6
Route
ORAL
Published
Effective Date 2022-07-25
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Biotin (30 ug) Vanadium (15 mg) Chromic Cation (200 ug) Gymnema Sylvestre Leaf (100 mg) Arginine (60 ug) .alpha.-tocopherol, Dl- (13.5 mg) Phytonadione (90 ug) Vitamin A (900 ug) Ascorbic Acid (50 mg) Cholecalciferol (18.75 ug) Pyridoxine (8 mg) Riboflavin (4 mg) Niacin (24 mg) Levomefolic Acid (1000 ug) Methylcobalamin (8 ug) Pantothenic Acid
Inactive Ingredients
Silicon Dioxide Hypromelloses Stevia Rebaudiuna Leaf Polyethylene Glycol 400 Croscarmellose Sodium Magnesium Stearate Cellulose, Microcrystalline Stearic Acid Dibasic Calcium Phosphate Dihydrate

Identifiers & Packaging

Pill Appearance
Shape: capsule Color: green Size: 19 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-01-26

Description

Vitamin A (as Retinyl Acetate).................................... 900 mcg RAE Vitamin C (as Ascorbic Acid)................................................. 50 mg Vitamin D3 (as Cholecalciferol)....................................... 18.75 mcg Vitamin E (as DL-Alpha Tocopheryl Acetate)...................... 13.5 mg Vitamin K1 (as Phytonadione)............................................. 90 mcg Thiamin (as Thiamine Mononitrate)......................................... 4 mg Riboflavin ................................................................................. 4 mg Niacin (as Niacinamide)......................................................... 24 mg Vitamin B6 (as Pyridoxine Hydrochloride)............................... 8 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)........................................ 8 mcg Biotin (as D-biotin)............................................................... 30 mcg Pantothenic Acid ...................................................................... 8 mg Chromium (as Chromium Nicotinate)............................... 200 mcg Gymnema Sylvestre Leaf Powder........................................ 100 mg L-Arginine HCl...................................................................... 60 mcg Vanadyl Sulfate....................................................................... 15 mg

Indications and Usage

Diatrol™ is indicated to provide significant amounts of essential vitamins and mineral. This comprehensive nutrient profile helps prevent nutritional deficiencies of these vitamins and minerals, ensuring that the specific dietary needs are met to support overall health, energy, and vitality. The product is specially formulated to target common vitamin and mineral gaps, thus promoting optimal health, immune function, bone strength, and metabolic balance. It is intended to be used under the guidance of a licensed healthcare practitioner to ensure that any potential for nutritional deficiency is addressed in a manner that supports the individual's overall health and wellbeing.

Dosage and Administration

Take one (1) caplet daily or as directed by a licensed healthcare practitioner.

Contraindications

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

Adverse Reactions

Folate: Allergic sensitizations 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.

How Supplied

Diatrol™ caplets are light green with brown speckles and dispensed in a child-resistant bottle containing 30 caplets (NDC 59088-162-54). All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.


Medication Information

Indications and Usage

Diatrol™ is indicated to provide significant amounts of essential vitamins and mineral. This comprehensive nutrient profile helps prevent nutritional deficiencies of these vitamins and minerals, ensuring that the specific dietary needs are met to support overall health, energy, and vitality. The product is specially formulated to target common vitamin and mineral gaps, thus promoting optimal health, immune function, bone strength, and metabolic balance. It is intended to be used under the guidance of a licensed healthcare practitioner to ensure that any potential for nutritional deficiency is addressed in a manner that supports the individual's overall health and wellbeing.

Dosage and Administration

Take one (1) caplet daily or as directed by a licensed healthcare practitioner.

Contraindications

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

Adverse Reactions

Folate: Allergic sensitizations 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.

How Supplied

Diatrol™ caplets are light green with brown speckles and dispensed in a child-resistant bottle containing 30 caplets (NDC 59088-162-54). All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Description

Vitamin A (as Retinyl Acetate).................................... 900 mcg RAE Vitamin C (as Ascorbic Acid)................................................. 50 mg Vitamin D3 (as Cholecalciferol)....................................... 18.75 mcg Vitamin E (as DL-Alpha Tocopheryl Acetate)...................... 13.5 mg Vitamin K1 (as Phytonadione)............................................. 90 mcg Thiamin (as Thiamine Mononitrate)......................................... 4 mg Riboflavin ................................................................................. 4 mg Niacin (as Niacinamide)......................................................... 24 mg Vitamin B6 (as Pyridoxine Hydrochloride)............................... 8 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)........................................ 8 mcg Biotin (as D-biotin)............................................................... 30 mcg Pantothenic Acid ...................................................................... 8 mg Chromium (as Chromium Nicotinate)............................... 200 mcg Gymnema Sylvestre Leaf Powder........................................ 100 mg L-Arginine HCl...................................................................... 60 mcg Vanadyl Sulfate....................................................................... 15 mg

Storage

Do not use if bottle seal is broken.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.


Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from light and moisture and avoid excessive heat.

Warning

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Diatrol™

Manufactured in the USA by:

PureTek Corporation


Panorama City, CA 91402

Questions? Call toll-free:

1-877-921-7873

Precautions

Folate 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 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 licensed 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.

Adverse Reactions:

Folate: Allergic sensitizations 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 known hypersensitivity to any of its ingredients.

Other Ingredients:

Croscarmellose Sodium, Dicalcium Phosphate, Hydroxypropyl Methylcellulose, Magnesium Stearate (Vegetable Source), Microcrystalline Cellulose, PEG-8, Silicon Dioxide, Stearic Acid (Vegetable), Stevia Rebaudiana Leaf Extract, Flavor.

Each Caplet Contains:



Vitamin A (as Retinyl Acetate).................................... 900 mcg RAE

Vitamin C (as Ascorbic Acid)................................................. 50 mg

Vitamin D3 (as Cholecalciferol)....................................... 18.75 mcg

Vitamin E (as DL-Alpha Tocopheryl Acetate)...................... 13.5 mg

Vitamin K1 (as Phytonadione)............................................. 90 mcg

Thiamin (as Thiamine Mononitrate)......................................... 4 mg

Riboflavin ................................................................................. 4 mg

Niacin (as Niacinamide)......................................................... 24 mg

Vitamin B6 (as Pyridoxine Hydrochloride)............................... 8 mg

Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE

(1000 mcg as L-5-Methylfolate)

Vitamin B12 (as Methylcobalamin)........................................ 8 mcg

Biotin (as D-biotin)............................................................... 30 mcg

Pantothenic Acid ...................................................................... 8 mg

Chromium (as Chromium Nicotinate)............................... 200 mcg

Gymnema Sylvestre Leaf Powder........................................ 100 mg

L-Arginine HCl...................................................................... 60 mcg

Vanadyl Sulfate....................................................................... 15 mg


Structured Label Content

Storage (STORAGE)

Do not use if bottle seal is broken.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.


Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from light and moisture and avoid excessive heat.

Warning (WARNING)

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Diatrol™

Manufactured in the USA by:

PureTek Corporation


Panorama City, CA 91402

Questions? Call toll-free:

1-877-921-7873

Precautions (PRECAUTIONS)

Folate 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 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 licensed 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)

Diatrol™ caplets are light green with brown speckles and dispensed in a child-resistant bottle containing 30 caplets (NDC 59088-162-54). All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Adverse Reactions:

Folate: Allergic sensitizations 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 known hypersensitivity to any of its ingredients.

Other Ingredients:

Croscarmellose Sodium, Dicalcium Phosphate, Hydroxypropyl Methylcellulose, Magnesium Stearate (Vegetable Source), Microcrystalline Cellulose, PEG-8, Silicon Dioxide, Stearic Acid (Vegetable), Stevia Rebaudiana Leaf Extract, Flavor.

Each Caplet Contains:



Vitamin A (as Retinyl Acetate).................................... 900 mcg RAE

Vitamin C (as Ascorbic Acid)................................................. 50 mg

Vitamin D3 (as Cholecalciferol)....................................... 18.75 mcg

Vitamin E (as DL-Alpha Tocopheryl Acetate)...................... 13.5 mg

Vitamin K1 (as Phytonadione)............................................. 90 mcg

Thiamin (as Thiamine Mononitrate)......................................... 4 mg

Riboflavin ................................................................................. 4 mg

Niacin (as Niacinamide)......................................................... 24 mg

Vitamin B6 (as Pyridoxine Hydrochloride)............................... 8 mg

Folate (as L-5-Methyltetrahydrofolate calcium salt)…1700 mcg DFE

(1000 mcg as L-5-Methylfolate)

Vitamin B12 (as Methylcobalamin)........................................ 8 mcg

Biotin (as D-biotin)............................................................... 30 mcg

Pantothenic Acid ...................................................................... 8 mg

Chromium (as Chromium Nicotinate)............................... 200 mcg

Gymnema Sylvestre Leaf Powder........................................ 100 mg

L-Arginine HCl...................................................................... 60 mcg

Vanadyl Sulfate....................................................................... 15 mg

Indications and Usage (INDICATIONS AND USAGE)

Diatrol™ is indicated to provide significant amounts of essential vitamins and mineral. This comprehensive nutrient profile helps prevent nutritional deficiencies of these vitamins and minerals, ensuring that the specific dietary needs are met to support overall health, energy, and vitality. The product is specially formulated to target common vitamin and mineral gaps, thus promoting optimal health, immune function, bone strength, and metabolic balance. It is intended to be used under the guidance of a licensed healthcare practitioner to ensure that any potential for nutritional deficiency is addressed in a manner that supports the individual's overall health and wellbeing.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

Take one (1) caplet daily or as directed by a licensed healthcare practitioner.


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