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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated May 6, 2021

If you are a consumer or patient please visit this version.

  • 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

    Wellmind Calming Tablet .jpg

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:62795-1024
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP2 [hp_X]
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN12 [hp_X]
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE4 [hp_X]
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN2 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code mountain
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62795-1024-21 in 1 CARTON08/30/201407/30/2025
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/30/201407/30/2025
    Labeler - MediNatura Inc (079324099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MediNatura Inc102783016manufacture(62795-1024)