Label: RESCUE SLEEP- helianthemum nummularium flower, clematis vitalba flower, impatiens glandulifera flower, prunus cerasifera flower, ornithogalum umbellatum, and aesculus hippocastanum flower capsule, liquid filled

  • 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 October 6, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients Each 5X (HPUS)Purpose
    Rock Rose
    (Helianthemum nummularium)    		Courage and presence of mind
    Clematis
    (Clematis vitalba)    		Focus when ungrounded
    Impatiens
    (Impatiens glandulifera)    		Patience with problems and people
    Cherry Plum
    (Prunus cerasifera)    		Balanced mind when losing control
    Star of Bethlehem
    (Ornithogalum umbellatum)    		Softens impact of shock
    White Chestnut
    (Aesculus hippocastanum)    		Relief from repetitive thoughts
  • Uses

    • provides natural relief of occasional sleeplessness caused by stress and repetitive thoughts
  • Warnings

    Stop use and ask a doctor if sleeplessness persists for more than two weeks. Insomnia can be a symptom of serious underlying illness.

    If pregnant or breast-feeding, ask a doctor before use.

    Keep out of reach of children. In case of overdose, contact a medical professional or Poison Control Center right away.

  • Directions

    • place 1 capsule on tongue and let dissolve prior to going to bed. Additional capsules may be taken as needed.
    • use adult supervision when administering to children under 12
  • Other information

    • store below 77°F (25°C)
    • do not use if tamper-evident foil backing is damaged or broken
    • active ingredients made according to the Homeopathic Pharmacopoeia of the United States (HPUS)
  • Inactive ingredients

    carnauba wax, coconut oil, gelatin (fish), grapeseed oil, natural orange flavor, natural vanilla flavor, pectin, sorbitol

  • Questions?

    1-800-319-9151
    Monday-Friday 8am-5pm (EST)

  • SPL UNCLASSIFIED SECTION

    Distributed by Nelson Bach USA Ltd, North Andover, MA 01845

  • PRINCIPAL DISPLAY PANEL - 28 Capsule Blister Pack Carton

    NDC #57687-291-28

    Bach ®
    ORIGINAL
    FLOWER REMEDIES

    28 CAPSULES

    RESCUE
    SLEEP ®*
    LIQUID
    MELTS

    NATURAL SLEEP AID
    IN A CAPSULE †

    DISSOLVES ON
    TONGUE

    NON-HABIT
    FORMING

    ALCOHOL-FREE

    28 Capsules

    HOMEOPATHIC
    *See disclaimer on back panel

    PRINCIPAL DISPLAY PANEL - 28 Capsule Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    RESCUE SLEEP 
    helianthemum nummularium flower, clematis vitalba flower, impatiens glandulifera flower, prunus cerasifera flower, ornithogalum umbellatum, and aesculus hippocastanum flower capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57687-291
    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]
    CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI) (CLEMATIS VITALBA FLOWER - UNII:7SCP4N87CI) CLEMATIS VITALBA FLOWER5 [hp_X]
    IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV) IMPATIENS GLANDULIFERA FLOWER5 [hp_X]
    PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS) PRUNUS CERASIFERA FLOWER5 [hp_X]
    ORNITHOGALUM UMBELLATUM WHOLE (UNII: 9NS3M2Y78S) (ORNITHOGALUM UMBELLATUM WHOLE - UNII:9NS3M2Y78S) ORNITHOGALUM UMBELLATUM WHOLE5 [hp_X]
    AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M) AESCULUS HIPPOCASTANUM FLOWER5 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    MARINE NON-GELLING GELATIN, HIGH MW (UNII: AHQ60JKI5D)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    VANILLA BEAN (UNII: Q74T35078H)  
    PECTIN (UNII: 89NA02M4RX)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeCAPSULE (sphere) Size5mm
    FlavorORANGE, VANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57687-291-282 in 1 CARTON02/24/2010
    114 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/24/2010
    Labeler - Nelson Bach USA, Ltd. (877720193)
    Registrant - A Nelson & Co Limited (221471234)
    Establishment
    NameAddressID/FEIBusiness Operations
    A. Nelson & Co. Limited221471234analysis(57687-291)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wasdell Packaging Limited217351428pack(57687-291)
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