FDA.reportPublic FDA data

WellMind Calming

Manufacturer
MediNatura Inc
Effective date
2023-04-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:20:56

Label at a glance#

ProductWellMind Calming
Active ingredientMATRICARIA CHAMOMILLA WHOLE, ARABICA COFFEE BEAN, HOPS, STRYCHNOS IGNATII SEED, MOSCHUS MOSCHIFERUS MUSK SAC RESIN, STRYCHNOS NUX-VOMICA SEED, PASSIFLORA INCARNATA FLOWERING TOP, SULFUR, VALERIAN, VERATRUM ALBUM ROOT
Label structure8 sections

Indications and uses

For the temporary relief of simple nervous tension and anxiousness to promote better natural sleep.

Dosage and administration

For max absorption, dissolve under tongue. Can be chewed and swallowed. 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. Standard dosage: Adults and children 12 years and older : take 2 tablets in the moning and 2 tablets in the evening. For children under 12 years , consult your health professional.  

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 simple nervous tension and anxiousness to promote better natural sleep.

WARNINGS

WARNINGS SECTION

Warnings: Do not give to children under 12 years of age.If pregnant or breast-feeding, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN.  If symptoms persist or worsen, a health professional should be consulted. Do not use if known sensitivity to WellMind or any of it's ingredients exists.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

For max absorption, dissolve under tongue. Can be chewed and swallowed. 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.Standard dosage: Adults and children 12 years and older: take 2 tablets in the moning and 2 tablets in the evening. For children under 12 years, consult your health professional.  

PURPOSE

OTC - PURPOSE SECTION

Calmer Minds

Sleep Deeper

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Chamomilla 2X, Coffea cruda 10X, Humulus lupulus 2X, Ignatia amara 8X, Moschus 10X,
Nux-vomoica 30X, Passiflora incarnata 2X, Sulphur 12X, Valeriana officinalis 2X, Veratrum album 4X

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

*Dextrose, *Lactose, Magnesium Stearate, *Maltodextrin
*contains one or more of these ingredients.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WellMind CalmingWellMind Calming

Add image transcription here...

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62795-1043-22025-01-30C16284748780-12cef2736-6e44-d83d-e063-dadaa90ab31fWellMind Calming

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62795-1043-2WellMind Calming1 in 1 CARTONTABLET13
62795-1043-2WellMind Calming100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62795-1043WELLMIND CALMING (MATRICARIA CHAMOMILLA WHOLE,ARABICA COFFEE BEAN,HOPS,STRYCHNOS IGNATII SEED,MOSCHUS MOSCHIFERUS MUSK SAC RESIN,STRYCHNOS NUX-VOMICA SEED,PASSIFLORA INCARNATA FLOWERING TOP,SULFUR,VALERIAN AND VERATRUM ALBUM ROOT) TABLET [MEDINATURA INC]3Legacy NDC, 2 package rows20230420_df97b188-efa3-4432-b9f0-5afe33a04136.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62795-1043-2EA - Each62795-1043a318d729-a5ad-4243-b6d0-6e227a2cc30012022-05-04

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62795-104362795-1043-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
MATRICARIA CHAMOMILLA WHOLEG0R4UBI2ZZACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
HOPS01G73H6H83ACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
MOSCHUS MOSCHIFERUS MUSK SAC RESIN8KFK4W7KP7ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
SULFUR70FD1KFU70ACTIB
VALERIANJWF5YAW3QWACTIB
VERATRUM ALBUM ROOTQNS6W5US1ZACTIB
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT

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
8cd4867a-3371-4833-a882-19528bfb6278df97b188-efa3-4432-b9f0-5afe33a041362023-04-19WarningsExact identifier
spl id: 8cd4867a-3371-4833-a882-19528bfb6278
spl set id: df97b188-efa3-4432-b9f0-5afe33a04136

Reported adverse events (FAERS/openFDA)#

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