CALM AND SERENITY (ASAFOETIDA, LYCOPUS VIRGINICUS, SELENICEREUS GRANDIFLORUS STEM AND PASSIFLORA INCARNATA FLOWERING TOP) TABLET, ORALLY DISINTEGRATING [SIMILASAN CORPORATION]

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  • CALM AND SERENITY (ASAFOETIDA, LYCOPUS VIRGINICUS, SELENICEREUS GRANDIFLORUS STEM AND PASSIFLORA INCARNATA FLOWERING TOP) TABLET, ORALLY DISINTEGRATING [SIMILASAN CORPORATION]

CALM AND SERENITY (ASAFOETIDA, LYCOPUS VIRGINICUS, SELENICEREUS GRANDIFLORUS STEM AND PASSIFLORA INCARNATA FLOWERING TOP) TABLET, ORALLY DISINTEGRATING [SIMILASAN CORPORATION]
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NDC 59262-604-30
Set ID b81f8fcc-965b-42a8-8420-e34c6577c8b1
Category HUMAN OTC DRUG LABEL
Packager Similasan Corporation
Generic Name
Product Class
Product Number
Application Number
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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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