Label: SLEEPLESSNESS RELIEF- avena sativa and hepar sulphuris and pulsatilla and zincum valerianicum globule

  • 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 July 11, 2013

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

  • Active ingredient(s)

    Avena sativa 12X

  • Purpose

    sleeplessness, nervousness

  • Active ingredient(s)

    Hepar sulphuris 12X

  • Purpose

    restlessness

  • Active ingredient(s)

    Pulsatilla 15X

  • Purpose

    irregular/agitated sleep

  • Active ingredient(s)

    Zincum valerianicum 12X

  • Purpose

    sleeplessness

  • Uses:

    Relieves symptoms of occasional sleeplessness and/or restless sleep
    - Difficulty in going to sleep and frequent waking during the night
    - Disturbed sleep due to inability "to switch off", tenseness and restlessness
    - Restless, light sleep and excessive dreaming 

  • 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:
    - Remove tamper-evident seal from neck of bottle.
    - Twist cap off bottle.
    - Dispense 7-10 globules, place in mouth and allow to dissolve.  Do not swallow globules.
    - Allow the globules to dissolve in the mouth.

    Occasional Sleeplessness: Take in the evening before going to bed. If you don't find relief immediately, repeat every fifteen minutes.  Also take during the night if you wake frequently.

  • 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 59262-601-30
    Similasan
    Sleeplessness Relief
    Globules
    15g/ 0.529 oz

    Sleeplessness Relief Box

    Sleeplessness Relief Box

  • INGREDIENTS AND APPEARANCE
    SLEEPLESSNESS RELIEF 
    avena sativa and hepar sulphuris and pulsatilla and zincum valerianicum globule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-601
    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 TOP12 [hp_X]
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]
    ANEMONE PATENS (UNII: 4M1169RWJD) (ANEMONE PATENS - UNII:4M1169RWJD) ANEMONE PATENS15 [hp_X]
    ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B) ZINC VALERATE DIHYDRATE12 [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:59262-601-301078 in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC07/02/2013
    Labeler - Similasan Corporation (111566530)