FDA Label for Diatrol
View Indications, Usage & Precautions
Diatrol Product Label
The following document was submitted to the FDA by the labeler of this product Puretek Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
* Please review the disclaimer below.