Label: HOMEOPATHIC SLEEP FORMULA- avena sativa, chamomilla vulgaris, humulus lupulus, passiflora incarnata, coffea cruda, ignatia amara 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 March 25, 2011

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  • ACTIVE INGREDIENT

    I n g r e d i e n t s :

    Oatstraw.............................. 3X HPUS
    Chamomile.................... 3X HPUS
    Hops......................... 3X HPUS
    Passion flower.................... 3X HPUS
    Green coffee.............................. 3C HPUS
    Ignatius bean............................. 3C HPUS


    The letters “HPUS” indicate that the components in
    this product are officially monographed in the
    Homeopathic Pharmacopoeia of the United States.

  • PURPOSE

    For the relief of occasional sleeplessness and to help you sleep

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF
    REACH OF CHILDREN.

  • INDICATIONS & USAGE

    For the relief of occasional sleeplessness and to help you sleep

  • WARNINGS

    Warning: If you are taking any medications or
    are pregnant or breast feeding do not use prior to
    consulting a physician.

  • DOSAGE & ADMINISTRATION


    Suggested Use: Adults and children over 12
    years, take 1-2 tablets, dissolve under tongue or
    chew 3 times a day or as directed by a health care
    professional. Take 15 minutes before or after meals.
    If symptoms persist for more than 7 days consult a
    health professional.
  • INACTIVE INGREDIENT

    Inactive Ingredients: Dextrose, Magnesium
    Stearate, Silica.

  • PRINCIPAL DISPLAY PANEL

    NDC# 1057802490

    Homeopathic Sleep Formula

    For the relief of occasional sleeplessness and to help you sleep

    300 mg.
    90 Tablets



    image of label





  • USER SAFETY WARNINGS

    For your protection, this container has an outer
    safety seal. (Do not accept if missing or broken.)
    Best if used by date on bottle. Store in a dry cool place.
    Any Questions? 1-800-644-8327
    website: www.botanicchoice.com

  • SPL UNCLASSIFIED SECTION

    FDA Establishment #: 1811575

    Distributed by: Indiana Botanic Gardens, Inc.
    3401 W. 37th Ave. Hobart, IN 46342

  • INGREDIENTS AND APPEARANCE
    HOMEOPATHIC SLEEP FORMULA 
    avena sativa, chamomilla vulgaris, humulus lupulus, passiflora incarnata, coffea cruda, ignatia amara tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10578-024
    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 TOP3 [hp_X]
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA3 [hp_X]
    HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS3 [hp_X]
    PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA TOP3 [hp_X]
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN3 [hp_C]
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED3 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize3mm
    FlavorImprint Code H;367
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10578-024-9090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/2001
    Labeler - Indiana Botanic Gardens (005421771)
    Registrant - Indiana Botanic Gardens (005421771)
    Establishment
    NameAddressID/FEIBusiness Operations
    Indiana Botanic Gardens005421771label
    Establishment
    NameAddressID/FEIBusiness Operations
    ASI Marketing Group964366611manufacture
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