Label: BACH PASTILLES ORANGE AND ELDERFLOWER- helianthemum nummularium whole, prunus cerasifera whole, ornithogalum umbellatum, clematis vitalba whole, and impatiens glandulifera whole lozenge

  • NDC Code(s): 57687-245-50
  • 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 October 21, 2020

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  • Uses

    For relief of occasional stress.

  • Directions

    Dissolve 1 Pastille in mouth as required.

  • Active Ingredients Each 5X (HPUS)

    Cherry Plum (Prunus cerasifera), Clematis (Clematis vitalba), Impatiens (Impatiens glandulifera), Rock Rose (Helianthemum nummularium), Star of Bethlehem (Ornithogalum umbellatum).

  • Inactive Ingredients

    Beeswax, elderflower (as flavor), gum arabic, isomalt, maltitol, orange (as flavor), sorbitol, sustainable palm kernel oil, xylitol.

  • Warnings

    Do not use if seal is broken. Ask a doctor before use in children under 12. Excessive consumption may induce mild laxative effects. If pregnant or breastfeeding, ask a doctor before use.

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

  • Other Information

    Store below 77ºF (25ºC). Not suitable for animals.

  • Questions?

    Call 1-800-319-9151 Mon-Fri 8am-5pm EST.

  • SPL UNCLASSIFIED SECTION

    Distributed by Nelson Bach USA Ltd.,
    21 High Street, Suite 302, North Andover, MA 01845.

  • PRINCIPAL DISPLAY PANEL - 50 g Pastille Container Label

    RESCUE

    NDC# 57687-245-50

    ORANGE & ELDERFLOWER FLAVOR

    Bach®
    ORIGINAL
    FLOWER REMEDIES

    RESCUE®
    PASTILLES*

    NATURAL STRESS RELIEF†

    TRUSTED WORLDWIDE
    FOR GENERATIONS

    50g (1.7 oz)
    35 Pastilles ℮
    Homeopathic

    *See disclaimer on back panel

    3002678

    PRINCIPAL DISPLAY PANEL - 50 g Pastille Container Label
  • INGREDIENTS AND APPEARANCE
    BACH PASTILLES ORANGE AND ELDERFLOWER 
    helianthemum nummularium whole, prunus cerasifera whole, ornithogalum umbellatum, clematis vitalba whole, and impatiens glandulifera whole lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57687-245
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Helianthemum nummularium whole (UNII: R0G6QEU3M0) (Helianthemum nummularium whole - UNII:R0G6QEU3M0) Helianthemum nummularium whole5 [hp_X]
    Prunus cerasifera whole (UNII: XVE14FEG0K) (Prunus cerasifera whole - UNII:XVE14FEG0K) Prunus cerasifera whole5 [hp_X]
    ORNITHOGALUM UMBELLATUM WHOLE (UNII: 9NS3M2Y78S) (ORNITHOGALUM UMBELLATUM WHOLE - UNII:9NS3M2Y78S) ORNITHOGALUM UMBELLATUM WHOLE5 [hp_X]
    Clematis vitalba whole (UNII: 7PH07Z124Q) (Clematis vitalba whole - UNII:7PH07Z124Q) Clematis vitalba whole5 [hp_X]
    Impatiens glandulifera whole (UNII: 21L92F0HMH) (Impatiens glandulifera whole - UNII:21L92F0HMH) Impatiens glandulifera whole5 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    Acacia (UNII: 5C5403N26O)  
    Sorbitol (UNII: 506T60A25R)  
    Maltitol (UNII: D65DG142WK)  
    Isomalt (UNII: S870P55O2W)  
    Orange Oil (UNII: AKN3KSD11B)  
    Xylitol (UNII: VCQ006KQ1E)  
    PALM KERNEL OIL (UNII: B0S90M0233)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize15mm
    FlavorORANGEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57687-245-5035 in 1 CONTAINER; Type 0: Not a Combination Product11/20/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC11/20/2006
    Labeler - Nelson Bach USA Limited (877720193)
    Registrant - A. Nelson & Co. Limited (221471234)
    Establishment
    NameAddressID/FEIBusiness Operations
    A. Nelson & Co Ltd221471234PACK(57687-245) , LABEL(57687-245) , ANALYSIS(57687-245)
    Establishment
    NameAddressID/FEIBusiness Operations
    Disch AG480002609MANUFACTURE(57687-245)
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