ADVERSE REACTIONS SECTION.

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.

DESCRIPTION SECTION.

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

HOW SUPPLIED SECTION.

HOW SUPPLIED. Diatrol(TM) caplets are light green with brown speckles and dispensed in 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.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Diatrol(TM) 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 licensed healthcare practitioner to ensure that any potential for nutritional deficiency is addressed in manner that supports the individuals overall health and wellbeing. Contraindications:. This product is contraindicated in patients with known hypersensitivity to any of its ingredients.

PRECAUTIONS SECTION.

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 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 patients medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.For use on the order of 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.

SPL UNCLASSIFIED SECTION.

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.

STORAGE AND HANDLING SECTION.

STORAGE. Do not use if bottle seal is broken. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Protect from light and moisture and avoid excessive heat.