Label: CALM AND SERENITY- asafoetida, lycopus virginicus, selenicereus grandiflorus stem and passiflora incarnata flowering top tablet, orally disintegrating

  • 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 December 12, 2016

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  • SPL UNCLASSIFIED SECTION

    Calm & Serenity

    Drug Facts

  • Active Ingredients

    Asafoetida (Hing) 4X

  • Purpose

    apprehension, irritability, restlessness

  • Active Ingredients

    Cactus grandiflorus 4X

  • Purpose

    nervousness, restless sleep

  • Active Ingredients

    Lycopus virginicus (Sweet Bugle) 3X

  • Purpose

    inner tension, palpitations

  • Active Ingredients

    Passiflora (Passionflower) 4X

  • Purpose

    restless sleep from exhaustion

  • Uses*

    According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:

    • inner tension

    • apprehension

    • restlessness

    • nervous sleeplessness, general irritability and tension

  • Warnings

    • According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).

    • Consult a physician if symptoms worsen or persist for more than 72 hours.

    If pregnant, trying to get pregnant or breast feeding, ask a health professional before use.

    Keep out of reach of children.

    In case of accidental overdose get medical help, or contact a Poison Control Center right away.

  • Directions

    For adults and children ages 12 and above:

    Dissolve 1 tablet in mouth every 15 minutes, up to 12 doses per day. Tablet may also be dissolved in a glass of water.

  • Other Information

    Active ingredients are manufactured according to homeopathic principles.

  • Inactive Ingredients

    Lactose, Magnesium stearate

  • Questions?

    Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com.

    www.SimilasanUSA.com

    *These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

  • PRINCIPAL DISPLAY PANEL

    NDC 59262-604-30
    Calm &
    Serenity
    Asafoetida &
    Passionflower
    Actives
    60 Dissolvable Tablets

    PRINCIPAL DISPLAY PANEL NDC 59262-604-30 Calm & Serenity Asafoetida & Passionflower Actives 60 Dissolvable Tablets

  • INGREDIENTS AND APPEARANCE
    CALM AND SERENITY 
    asafoetida, lycopus virginicus, selenicereus grandiflorus stem and passiflora incarnata flowering top tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-604
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA4 [hp_X]
    SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK) SELENICEREUS GRANDIFLORUS STEM4 [hp_X]
    LYCOPUS VIRGINICUS (UNII: TWH5125Q6F) (LYCOPUS VIRGINICUS - UNII:TWH5125Q6F) LYCOPUS VIRGINICUS3 [hp_X]
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP4 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-604-3060 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC02/01/2017
    Labeler - Similasan Corporation (111566530)
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