WellMind Calming Tablet

Manufacturer
MediNatura Inc
Effective date
2021-05-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:45:12

Label at a glance#

ProductWellMind Calming
Active ingredientAVENA SATIVA FLOWERING TOP, ARABICA COFFEE BEAN, PASSIFLORA INCARNATA FLOWERING TOP, SEPIA OFFICINALIS JUICE, VALERIAN
Label structure8 sections

Indications and uses

For the temporary relief of minor, occasional simple nervous tension & irratability to help occasional sleeplessness.

Dosage and administration

At first sign of symptoms: Adults and children 12 years and older: 1 tablet every ½ to 1 hour until symptoms lessen, then continue with standard dosage. Do not exceed 12 tablets in 24 hours. For children under 12 years , consult your health professional. Standard dosage: Adults and children 12 years and older: 3 tablets per day, taking 1 tablet every 4 to 6 hours. For children under 12 years, consult your health p...

Label contents#

Full prescribing information#

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor, occasional simple nervous tension & irratability to help occasional sleeplessness.

WARNINGS

WARNINGS SECTION

Do not give to children under 12 years of age.If pregnant or breast-feeding, ask a health professional before use. If sleeplessness or nervous tension persists continuously for more than two weeks, a health professional should be consulted. Insomnia may be a symptom of serious underlying medical illness. Due to the homeopathic nature of WellMind Calming, a temporary worsening in symptoms (initial aggravation) may occur, but often resolves quickly. Allergic (hypersensitivity) skin reactions may occur in very rare casses. Do not use if known sensitivity to Wellmind Calming or any of its ingredients exists. 

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

At first sign of symptoms: Adults and children 12 years and older: 1 tablet every ½ to 1 hour until symptoms lessen, then continue with standard dosage. Do not exceed 12 tablets in 24 hours. For children under 12 years, consult your health professional.

Standard dosage: Adults and children 12 years and older: 3 tablets per day, taking 1 tablet every 4 to 6 hours. For children under 12 years, consult your health professional.

Allow tablets to dissolve completely in the mouth, do not swallow.

PURPOSE

OTC - PURPOSE SECTION

Relieves

  • Nervous Tension
  • Irritability
  • Sleeplessness

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                     Purpose

*Avena sativa 2X.........................Relieves simple nervous tension

*Coffea cruda 12X.......................Relieves irritability 

*Passiflora incarnata3X................Relieves simple nervous tension

 *Sepia 4X...................................Relieves occasional nervous sleeplessness 

*Valeriana officinalis 2X................Relieves occasional nervous sleeplessness

*Valeriana officinalis 10X..............Relieves occasional nervous sleeplessness

 *Valeriana officinalis 30X.............Relieves occasional nervous sleeplessness

*NaturalIngredients

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Lactose, Magnesium stearate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Wellmind Calming Tablet .jpgWellmind Calming Tablet .jpg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62795-1024WELLMIND CALMING (AVENA SATIVA FLOWERING TOP, ARABICA COFFEE BEAN, PASSIFLORA INCARNATA FLOWERING TOP,SEPIA OFFICINALIS JUICE, AND VALERIAN) TABLET [MEDINATURA INC]4Legacy NDC20210508_894e79d9-beed-4dcc-8f07-7745e798daef.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62795-1024-2EA - Each62795-1024497e61fa-7de6-4b67-82fe-df10512faea112015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARABICA COFFEE BEANACTIVE INGREDIENT3SW678MX721
AVENA SATIVA FLOWERING TOPACTIVE INGREDIENTMA9CQJ3F7F1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE INGREDIENTCLF5YFS11O1
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C21
VALERIANACTIVE INGREDIENTJWF5YAW3QW1
ARABICA COFFEE BEANACTIVE MOIETY3SW678MX721
AVENA SATIVA FLOWERING TOPACTIVE MOIETYMA9CQJ3F7F1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE MOIETYCLF5YFS11O1
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C21
VALERIANACTIVE MOIETYJWF5YAW3QW1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62795-102462795-1024-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 75 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FOR SUSPENSION / ORAL131 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CREAM / TOPICALNAExact identifier — unii candidate
39 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS133 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, COATED / ORAL332.05 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / BUCCAL296.7 mgExact identifier — unii candidate
36 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30PELLET / ORAL24 mgExact identifier — unii candidate
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MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / INTRAVITREALNAExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL47 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING / ORAL187 mgExact identifier — unii candidate
39 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCONCENTRATE / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, EXTENDED RELEASE / ORAL400 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE / RESPIRATORY (INHALATION)44.4 mgExact identifier — unii candidate
36 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TROCHE / ORAL315 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY193.8 mgExact identifier — unii candidate
36 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30WAFER / ORAL66 mgExact identifier — unii candidate
39 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GOINTMENT / TOPICALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, COATED PELLETS / ORAL135.2 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, DELAYED RELEASE / ORAL231.84 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION / INTRAVENOUS203.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION / INTRAMUSCULAR203.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / BUCCAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GPOWDER / RESPIRATORY (INHALATION)90 mgExact identifier — unii candidate
36 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED, EXTENDED RELEASE / ORAL53 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30RING / VAGINAL2 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, EXTENDED RELEASE / ORAL117 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii candidate
39 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, SOLUTION / INTRAVENOUS0.45 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / TOPICAL104 mgExact identifier — unii candidate
39 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE / ORAL530 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GPOWDER / VAGINAL430 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GGRANULE, FOR SUSPENSION / ORAL512.5 mg/5mlExact identifier — unii candidate
36 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INSERT / VAGINAL69 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INHALANT / ORAL0.08 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SYSTEM / INTRAVITREAL0.02 mgExact identifier — unii candidate
39 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR133 mgExact identifier — unii candidate
36 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / ORAL25 mgExact identifier — unii candidate
39 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, EFFERVESCENT / ORAL96.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE, FOR SUSPENSION / ORAL14 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / SUBLINGUAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GFILM, EXTENDED RELEASE / TRANSDERMAL675 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GSUPPOSITORY / VAGINALNAExact identifier — unii candidate
36 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, COATED / ORAL184 mgExact identifier — unii candidate
39 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, FILM COATED / ORAL590 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION / ORAL64 mgExact identifier — unii candidate
39 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, FILM COATED, EXTENDED RELEASE / ORAL620 mgExact identifier — unii candidate
36 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30DROPS / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii candidate
39 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GSOLUTION / RECTAL8 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCREAM / VAGINAL3 %w/wExact identifier — unii candidate
36 equally ranked IID candidates

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
091d5a34-dbbb-455e-9825-9b807711eca8894e79d9-beed-4dcc-8f07-7745e798daef2021-05-06WarningsExact identifier
spl id: 091d5a34-dbbb-455e-9825-9b807711eca8
spl set id: 894e79d9-beed-4dcc-8f07-7745e798daef

Reported adverse events (FAERS/openFDA)#

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