Label: RESCUE SLEEP KIDS DROPPER- helianthemum nummularium flower, clematis vitalba flower, impatiens glandulifera flower, prunus cerasifera flower, ornithogalum umbellatum whole, and aesculus hippocastanum flower solution

  • NDC Code(s): 57687-244-10
  • Packager: Nelson Bach USA Limited
  • 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 27, 2023

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  • ACTIVE INGREDIENT

    (Each: equal parts 5X HPUS)

    Cherry Plum (Prunus cerasifera)

    Clematis (Clematis vitalba)

    Impatiens (Impatiens glandulifera)

    Rock Rose (Helianthemum nummularium)

    Star of Bethlehem (Ornithogalum umbellatum)

    White Chestnut (Aesculus hippocastanum)

    'HPUS' indicates ingredients are in the official Homeopathic Pharmacopoeia of the United States

  • PURPOSE

    Cherry Plum (Prunus cerasifera) - Balanced mind when losing control

    Clematis (Clematis vitalba) - Focus when undgrounded

    Impatiens (Impatiens glandulifera) - Patience with problems & people

    Rock Rose (Helianthemum nummularium) - Courage & presence of mind

    Star of Bethlehem (Ornithogalum umbellatum) - Softens impact of shock

    White Chestnut (Aesculus hippocastanum) - Relief from repetative thoughts

  • Use

    • for relief of occasional sleeplessness caused by stress and repetitive thoughts
  • WARNINGS

    Stop use and ask a doctor if sleeplessness persists for more than 2 weeks: insomnia can be a symptom of a serius underlying medical illness

    Keep out of reach of children.

  • Directions

    • children ages 2 and up: take 4 drops directly on tongue, or add to a beverage and sip. Additional drops may be taken during the night as needed.
    • children under 2: ask a doctor
  • Other information

    • do not use if tamper evident seal around bottle neck is missing or broken
    • store below 77°F (25°C)
  • Inactive ingredients

    glycerin [vegetable], purified water

  • Questions

    call 1-800-319-9151 Mon–Fri 8am–5pm (EST)

  • PRINCIPAL DISPLAY PANEL

    Rescue Sleep Kids dropper

  • INGREDIENTS AND APPEARANCE
    RESCUE SLEEP KIDS  DROPPER
    helianthemum nummularium flower, clematis vitalba flower, impatiens glandulifera flower, prunus cerasifera flower, ornithogalum umbellatum whole, and aesculus hippocastanum flower solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57687-244
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HELIANTHEMUM NUMMULARIUM FLOWER (UNII: 51BRR32WPP) (HELIANTHEMUM NUMMULARIUM FLOWER - UNII:51BRR32WPP) HELIANTHEMUM NUMMULARIUM FLOWER5 [hp_X]  in 0.095 mL
    CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI) (CLEMATIS VITALBA FLOWER - UNII:7SCP4N87CI) CLEMATIS VITALBA FLOWER5 [hp_X]  in 0.095 mL
    IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV) IMPATIENS GLANDULIFERA FLOWER5 [hp_X]  in 0.095 mL
    PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS) PRUNUS CERASIFERA FLOWER5 [hp_X]  in 0.095 mL
    ORNITHOGALUM UMBELLATUM WHOLE (UNII: 9NS3M2Y78S) (ORNITHOGALUM UMBELLATUM WHOLE - UNII:9NS3M2Y78S) ORNITHOGALUM UMBELLATUM WHOLE5 [hp_X]  in 0.095 mL
    AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M) AESCULUS HIPPOCASTANUM FLOWER5 [hp_X]  in 0.095 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57687-244-101 in 1 CARTON01/01/2021
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2021
    Labeler - Nelson Bach USA Limited (877720193)
    Registrant - A. Nelson & Co. Limited (221471234)
    Establishment
    NameAddressID/FEIBusiness Operations
    A. Nelson & Co. Limited221471234manufacture(57687-244)
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