Label: SLEEP AND DREAM- anemone pulsatilla, avena sativa flowering top, calcium sulfide and zinc valerate dihydrate 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 December 12, 2016

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  • SPL UNCLASSIFIED SECTION

    Sleep & Dream

    Drug Facts

  • Active Ingredients

    Avena sativa (Wild Oat) 12X

  • Purpose

    sleeplessness, nervousness

  • Active Ingredients

    Hepar sulphuris calcareum 12X

  • Purpose

    restlessness

  • Active Ingredients

    Pulsatilla (Pasque Flower) 15X

  • Purpose

    irregular or agitated sleep

  • Active Ingredients

    Zincum valerianicum 12X

  • Purpose

    sleeplessness

  • Uses*

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

    • occasional sleeplessness and/or restless, light sleep

    • difficulty in going to sleep and frequent waking during the night

    • disturbed sleep due to inability “to switch off”, tenseness and restlessness

  • 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 2 and above:

    Take 1-2 tablets 1 hour before bedtime and then again at bedtime or as needed. 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 59262-603-30
    Sleep & Dream
    Pasque Flower &
    Wild Oat Actives
    60 Dissolvable Tablets

    PRINCIPAL DISPLAY PANEL NDC 59262-603-30 Sleep & Dream Pasque Flower & Wild Oat Actives 60 Dissolvable Tablets

  • INGREDIENTS AND APPEARANCE
    SLEEP AND DREAM 
    anemone pulsatilla, avena sativa flowering top, calcium sulfide and zinc valerate dihydrate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-303
    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 PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA15 [hp_X]
    ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B) ZINC VALERATE DIHYDRATE12 [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:59262-303-3060 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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