Menatrol

Manufacturer
PureTek Corporation
Effective date
2023-12-18
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:56:38

Label at a glance#

ProductMenatrol
Active ingredientPYRIDOXINE HYDROCHLORIDE, CHOLECALCIFEROL, LEVOMEFOLATE CALCIUM, MAGNESIUM OXIDE, RHUBARB, CALCIUM CARBONATE
Label structure16 sections

Boxed warning

Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breast-feeding. Consult your doctor. Administration of folate alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient. Folate in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur w...

Indications and uses

For the dietary management of menopausal symptoms and the support of overall health during the menopausal phase.

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

DESCRIPTION:

DESCRIPTION SECTION

Full Prescribing Information:
Drug Description:
Menatrol™ Capsules are a comprehensive dietary supplement tailored for individuals undergoing menopause. This specialized formulation offers a blend of vitamins, minerals, and plant extracts aiming to alleviate common menopausal symptoms:

Vitamin D3 (Cholecalciferol): Contained in a dose of 15 mcg (600 IU), Vitamin D3 plays a pivotal role in maintaining bone health and may also help mitigate mood disturbances. It is recommended to seek a supplement offering 600-800 IU of Vitamin D3 daily, although personal dosing should be discussed with a licensed healthcare practitioner.
Vitamin B6 (Pyridoxine Hydrochloride): At a dosage of 1.5 mg, Vitamin B6 is integral for mood stabilization and promoting energy. Typically, adults are advised to consume 1.3-2.0 mg per day. Always refer to the supplement label for specific dosages.
Folate (L-5-Methyltetrahydrofolate calcium salt): Provided in a measure of 1700 mcg DFE (with 1000 mcg as L-5-Methylfolate), folate is pivotal for holistic health, potentially aiding in mood enhancement and energy regulation. An average adult dosage is between 400-800 mcg daily.
Calcium (Calcium Carbonate): At a concentration of 220 mg, calcium is a key mineral that fortifies bones, particularly crucial during menopause due to heightened osteoporosis risks. Women over 50 typically require around 1000-1300 mg of calcium daily, although intake should be calibrated based on diet.
Magnesium (Magnesium Oxide): Present in an amount of 100 mg, magnesium offers relief from muscle cramps, mood fluctuations, and sleep disturbances. On average, adults are recommended to consume 300-400 mg per day, though individual requirements can differ.
Rhapontic Rhubarb: Rhapontic rhubarb (Rheum rhaponticum) is a natural ingredient that some women use to address menopausal symptoms, including hot flashes and mood swings. The appropriate dosage for this specific ingredient may vary, so consult the product label or a licensed healthcare practitioner for guidance.

Each capsule contains:
Vitamin D3 (as Cholecalciferol)....................................15 mcg (600 IU)
Vitamin B6 (as Pyridoxine Hydrochloride)....................1.5 mg
Folate (as L-5-Methyltetrahydrofolate calcium salt)......1700 mcg DFE (1000 mcg as L-5-Methylfolate)
Calcium (as Calcium Carbonate)..................................220 mg
Magnesium (as Magnesium Oxide)..............................100 mg
Rhapontic Rhubarb (Siberian Rhubarb) Root Extract...4 mg

Other Ingredients:

SPL UNCLASSIFIED SECTION

DL-Alpha Tocopheryl Acetate, Magnesium Stearate, Microcrystalline Cellulose, Vegetable Capsule.

Indications and Usage:

INDICATIONS & USAGE SECTION

For the dietary management of menopausal symptoms and the support of overall health during the menopausal phase.

Contraindications:

CONTRAINDICATIONS SECTION

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Menatrol™ Capsules are contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

Warnings:

BOXED WARNING SECTION

Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breast-feeding. Consult your doctor. Administration of folate alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.

Precautions

PRECAUTIONS SECTION

Folate in 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. The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

Adverse Reactions:

ADVERSE REACTIONS SECTION

Possible side effects may include gastrointestinal upset. If any side effects persist or worsen, discontinue use and consult a physician.

Drug Interactions:

DRUG INTERACTIONS SECTION

Consult with a licensed healthcare practitioner before use if taking prescription medications, especially those affecting bone health or hormonal therapies.

Pregnancy and Lactation:

PREGNANCY SECTION

Not recommended for use during pregnancy or lactation without consulting with a licensed healthcare practitioner.

Overdosage:

OVERDOSAGE SECTION

In case of overdose, seek medical attention immediately. Symptoms may include nausea, vomiting, or diarrhea.

Clinical Pharmacology:

CLINICAL PHARMACOLOGY SECTION

The ingredients in this formulation work synergistically to potentially alleviate various menopausal symptoms by supporting bone health, mood regulation, and overall wellness.

Nonclinical Toxicology:

NONCLINICAL TOXICOLOGY SECTION

There are no known toxicities associated with the recommended doses of the ingredients in this supplement.

Clinical Studies:

CLINICAL STUDIES SECTION

Several ingredients in this supplement have been clinically studied for their effectiveness in managing menopausal symptoms, including bone health, mood disturbances, and overall well-being.

Dosage and Administration:

DOSAGE & ADMINISTRATION SECTION

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

How Supplied:

HOW SUPPLIED SECTION

Menatrol™Capsules are light yellow powder with black specks, encased in a hard shell capsule. They are packaged in bottle containing 30 capsules – NDC 59088-156-54. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.

Storage

STORAGE AND HANDLING SECTION

Do not use if bottle seal is broken.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP]. Protect from light and moisture and avoid excessive heat.

Menatrol™

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free: 877-921-7873

LabelLabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LEVOMEFOLIC ACID Pharmacologic Class Indexing1Indexing - Pharmacologic Class20230428
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
RHUBARB Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-156-54Menatrol30 in 1 BOTTLE, PLASTICCAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-156MENATROL (FOLATE, MULTIVITAMIN) CAPSULE [PURETEK CORPORATION]1Current NDC, 1 package rows20231219_0a100e7d-3a8d-2d8b-e063-6394a90a3203.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-156-54EA - Each59088-156f26dd7b1-a013-43ab-9902-ec3412d5028a12024-01-04

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-15659088-156-54

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MenatrolFOLATE, MULTIVITAMINPureTek Corporation0a100e7d-3a8d-2d8b-e063-6394a90a32032023-12-18Boxed warning, Adverse reactionsExact identifier
ndc (package): 59088-156-54
ndc (product): 59088-156
ndc11 (package): 59088015654
spl id: 0a100e7d-3a8e-2d8b-e063-6394a90a3203
spl set id: 0a100e7d-3a8d-2d8b-e063-6394a90a3203

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.