Label: SLEEP RELIEF- arsenic trioxide - arabica coffee bean - nitric acid - toxicodendron pubescens leaf - selenium - zinc - tablet, chewable

  • 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 November 14, 2012

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  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Arsenicum album 30C, HPUSRelieves anxiety and restlessness
    Coffea cruda 30C, HPUSRelaxes the mind
    Nitricum acidum 30C, HPUSRelieves frequent waking
    Rhus toxicodendron 30C, HPUSRelieves restlessness
    Selenium 30C, HPUSRelieves light sleeping
    Zincum metallicum 30C, HPUSRelieves restlessness

    "HPUS" indicates that the ingredient is officially included in the Homeopathic Pharmacopeia of the United States and the manufacturer has followed all guidelines set forth.

    Statement of Identity: Nighttime sleep aid.

  • PURPOSE

  • Uses

    For the relief of sleeplessness and to reduce the difficulty of falling asleep.

  • Warnings

    • Do not use if outer package seal is broken.
    • If sleeplessness persists for more than 2 weeks or worsens, consult a doctor. Insomnia may be a symptom of a serious underlying illness.
    • Do not give to children under 12 years of age.
  • PREGNANCY OR BREAST FEEDING

    • If pregnant or breast-feeding, consult a health professional before use.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • Directions

    (adults and children 12 years of age and older)

    Before bedtime chew two tablets thoroughly, allowing each to dissolve in the mouth, then swallow.

  • Other information

    • Safe to take with all other medications.
    • Store at 68-77°F (20-25°C) and keep out of direct sunlight.
    • Avoid humid or damp storage conditions. Close well when not in use.
  • Inactive Ingredients

    Lactose, magnesium stearate (vegetable source), stevia leaf extract.

  • DO NOT USE

  • Questions? Call toll free or email us at:

    1-888-60-B-WELL (1-888-602-9355)

    info@homeostasislabs.com

  • PRINCIPAL DISPLAY PANEL

    Box image
  • INGREDIENTS AND APPEARANCE
    SLEEP RELIEF 
    arsenic trioxide - arabica coffee bean - nitric acid - toxicodendron pubescens leaf - selenium - zinc - tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47242-0061
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE30 [hp_C]
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN30 [hp_C]
    NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID30 [hp_C]
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF30 [hp_C]
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM30 [hp_C]
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeDIAMOND (Rounded) Size11mm
    FlavorImprint Code H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47242-0061-11 in 1 PACKAGE
    150 in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2009
    Labeler - Homeostasis Laboratories, Inc. (010569196)
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