WELLMIND CALMING- avena sativa flowering top, arabica coffee bean, passiflora incarnata flowering top,sepia officinalis juice, and valerian tablet

WellMind Calming by

Drug Labeling and Warnings

WellMind Calming by is a Homeopathic medication manufactured, distributed, or labeled by MediNatura Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Uses

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

WARNINGS

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

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

Relieves

• Nervous Tension
• Irritability
• Sleeplessness

ACTIVE INGREDIENTS

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

Lactose, Magnesium stearate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WELLMIND CALMING 
avena sativa flowering top, arabica coffee bean, passiflora incarnata flowering top,sepia officinalis juice, and valerian tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62795-1024
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	2 [hp_X]
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	12 [hp_X]
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	3 [hp_X]
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	4 [hp_X]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	2 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	mountain
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62795-1024-2	1 in 1 CARTON	08/30/2014
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/30/2014

Labeler - MediNatura Inc (079324099)

Establishment
Name	Address	ID/FEI	Business Operations
MediNatura Inc		102783016	manufacture(62795-1024)