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Diatrol Prescribing Information

Package insert / product label
Generic name: vitamins and mineral
Dosage form: capsule
Drug class: Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Apr 15, 2024.

Diatrol 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

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 for Diatrol

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.

Warnings

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/Side Effects

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.

Diatrol Dosage and Administration

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

How is Diatrol 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 and Handling

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
vitamins and mineral capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59088-162
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN30 ug
VANADYL SULFATE (UNII: 6DU9Y533FA) (VANADIUM - UNII:00J9J9XKDE) VANADYL SULFATE15 mg
CHROMIUM NICOTINATE (UNII: A150AY412V) (CHROMIC CATION - UNII:X1N4508KF1) CHROMIUM NICOTINATE200 ug
GYMNEMA SYLVESTRE LEAF (UNII: 2ZK6ZS8392) (GYMNEMA SYLVESTRE LEAF - UNII:2ZK6ZS8392) GYMNEMA SYLVESTRE LEAF100 mg
ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y) (ARGININE - UNII:94ZLA3W45F) ARGININE HYDROCHLORIDE60 ug
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-13.5 mg
PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857) PHYTONADIONE90 ug
VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A900 ug
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID50 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL18.75 ug
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE8 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE4 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN4 mg
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN24 mg
LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM1000 ug
METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN8 ug
PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID8 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
Product Characteristics
Colorgreen (Light Green with Brown Speckles) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-162-5430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/26/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/26/2024
Labeler - PureTek Corporation (785961046)