MedPath

Diatrol

Diatrol

Approved
Approval ID

0fe2b1cf-9085-ea65-e063-6294a90a80a6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 1, 2024

Manufacturers
FDA

PureTek Corporation

DUNS: 785961046

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

vitamins and mineral

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59088-162
Product Classification
G
Generic Name
vitamins and mineral
Product Specifications
Route of AdministrationORAL
Effective DateApril 1, 2024
FDA Product Classification

INGREDIENTS (26)

STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
PANTOTHENIC ACIDActive
Quantity: 8 mg in 1 1
Code: 19F5HK2737
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
STEVIA REBAUDIUNA LEAFInactive
Code: 6TC6NN0876
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
PHYTONADIONEActive
Quantity: 90 ug in 1 1
Code: A034SE7857
Classification: ACTIB
BIOTINActive
Quantity: 30 ug in 1 1
Code: 6SO6U10H04
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ARGININE HYDROCHLORIDEActive
Quantity: 60 ug in 1 1
Code: F7LTH1E20Y
Classification: ACTIB
ASCORBIC ACIDActive
Quantity: 50 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
LEVOMEFOLATE CALCIUMActive
Quantity: 1000 ug in 1 1
Code: A9R10K3F2F
Classification: ACTIB
VANADYL SULFATEActive
Quantity: 15 mg in 1 1
Code: 6DU9Y533FA
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 18.75 ug in 1 1
Code: 1C6V77QF41
Classification: ACTIB
CHROMIUM NICOTINATEActive
Quantity: 200 ug in 1 1
Code: A150AY412V
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
VITAMIN AActive
Quantity: 900 ug in 1 1
Code: 81G40H8B0T
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 8 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIM
THIAMINE MONONITRATEActive
Quantity: 4 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
METHYLCOBALAMINActive
Quantity: 8 ug in 1 1
Code: BR1SN1JS2W
Classification: ACTIB
GYMNEMA SYLVESTRE LEAFActive
Quantity: 100 mg in 1 1
Code: 2ZK6ZS8392
Classification: ACTIB
RIBOFLAVINActive
Quantity: 4 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
NIACINActive
Quantity: 24 mg in 1 1
Code: 2679MF687A
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-Active
Quantity: 13.5 mg in 1 1
Code: WR1WPI7EW8
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/25/2022

Diatrol™

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

Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/25/2022

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.

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 7/25/2022

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.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 7/25/2022

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/25/2022

DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 7/25/2022

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 SECTION

LOINC: 34089-3Updated: 7/25/2022

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 7/25/2022

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.

WARNINGS SECTION

LOINC: 34071-1Updated: 7/25/2022

WARNING

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

PRECAUTIONS SECTION

LOINC: 42232-9Updated: 7/25/2022

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, callPureTek Corporation at1-877-921-7873 orFDAat1-800-FDA-1088or www.fda.gov/medwatch.

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