Diatrol Capsule
FDA Label NDC 59088-162

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puretek Corporation for the product Diatrol (NDC 59088-162). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding each caplet contains:, other ingredients:, indications and usage, contraindications:, warning, precautions, adverse reactions:, dosage and administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Each Caplet Contains:

→ Other Ingredients:

→ Indications And Usage

→ Contraindications:

→ Warning

→ Precautions

→ Adverse Reactions:

→ Dosage And Administration

→ How Supplied

→ Storage

→ Diatrol™

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

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.

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.

Contraindications:

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

Warning

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

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.

Dosage And Administration

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

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.

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.

Diatrol™

Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
Questions? Call toll-free:
1-877-921-7873

Label (Diatrol)

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