Label: STRESS AND TENSION RELIEF- asafetida, crataegus fruit, lycopus virginicus and passiflora incarnata flowering top globule

  • Category: HUMAN OTC DRUG LABEL

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 July 31, 2013

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  • Active ingredient(s)

    Asa foetida 4X

  • Purpose

    apprehension, irritability, restlessness

  • Active ingredient(s)

    Crataegus 4X

  • Purpose

    nervousness, restless sleep

  • Active ingredient(s)

    Lycopus virginicus 3X

  • Purpose

    inner tension, palpitations

  • Active ingredient(s)

    Passiflora 4X

  • Purpose

    restless sleep from exhaustion

  • Uses:

    Relieves symptoms of stress and simple nervous tension-
    - inner tension with palpitations
    - inner tension with gastro-intestinal cramps and nervous constipation
    - nervous digestive disorders
    - nervous sleeplessness, general irritability and tension

  • Warnings:

    - Consult a physician before use if pregnant or breast feeding.
    - Consult a physician if symptoms persist for more than 2 weeks or worsen.
    - Keep this and all medications out of the reach of children.
    - Do not use if tamper-evident seal is broken.
    - In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

    Keep out of reach of children

    Keep this and all medications out of the reach of children

  • Directions:

    For adults and children ages 2 and above:
    - twist cap off bottle breaking tamper-evident seal
    - unscrew cap from bottle
    - dispense 7-10 globules, for best results allow to dissolve in moith
    - take as needed up to every half hour

  • Other information:

    Active ingredients are microdiluted in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.

  • Inactive ingredients:

    Calcium carbonate, Xylitol (Sugar-free)

  • Questions?

    Call 1-800-240-9780 for 24hr recorded product information. Representatives available, M-F, 8am-5pm (MT), or visit: www.SimilasanUSA.com

  • Principal Display Panel

    NDC 59262-600-30
    Similasan
    Stress & Tension Relief
    Globules
    15g/ 0.529 oz

    Stress and Tension Relief box

    Stress and Tension Relief box

  • INGREDIENTS AND APPEARANCE
    STRESS AND TENSION RELIEF 
    asafetida, crataegus fruit, lycopus virginicus and passiflora incarnata flowering top globule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-600
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1) ASAFETIDA4 [hp_X]
    CRATAEGUS FRUIT (UNII: Q21UUL2105) (CRATAEGUS FRUIT - UNII:Q21UUL2105) CRATAEGUS FRUIT4 [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
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeFREEFORMSize1mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-600-301078 in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC07/02/2013
    Labeler - Similasan Corporation (111566530)
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