Label: THE FLOWER REMEDY PEACEFUL NIGHT- prunus cerasifera, clematis vitalba, ulmus procera, impatiens glandulifera, quercus robur, helianthemum nummularium, aesculus hippocastanum, ignatia amara liquid

  • 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 April 29, 2021

If you are a consumer or patient please visit this version.

  • Active Ingredients:

    Each 30ml bottle contains equal parts of the active ingredients:
    Each 5X (HPUS) Cherry Plum (Prunus cerasifera), Clematis (Clematis vitalba), Elm (Ulmus procera), Impatiens (Impatiens glandulifera), Oak (Quercus robur), Rock Rose (Helianthemum nummularium), White Chestnut (Aesculus hippocastanum), 200C (HPUS) Ignatia Amara

  • Purpose:

    Sleep Aid

  • USES:

    Relief from occasional sleeplessness

  • DIRECTIONS:

    Place 4 drops under the tongue 30-60 minutes before bed and as needed upon undesired awakening from sleep

  • WARNINGS:

    If pregnant or breast feeding, consult a physician before use. Consult a health care provider for children under 12. Consult a physician if symptoms persist for more than 7 days.

    Keep out of reach of children.

  • Inactive ingredients:

    water, alcohol

  • SPL UNCLASSIFIED SECTION

    THE FLOWER REMEDY
    NATURAL PRODUCTS

    Homeopathic Sleep Aid

    Homeopathic contains 27% alcohol

    *The claims for this product are based upon traditional homeopathic practice, not accepted medical practices. They have not been reviewed by the Food and Drug Administration.

    Manufactured and distributed by
    The Flower Remedy
    2921 Carlisle Blvd NE Suite 209
    Albuquerque, NM 87110
    (505) 263-7248

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    THE FLOWER REMEDY PEACEFUL NIGHT 
    prunus cerasifera, clematis vitalba, ulmus procera, impatiens glandulifera, quercus robur, helianthemum nummularium, aesculus hippocastanum, ignatia amara liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81183-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS) PRUNUS CERASIFERA FLOWER5 [hp_X]  in 30 mL
    CLEMATIS VITALBA FLOWER (UNII: 7SCP4N87CI) (CLEMATIS VITALBA FLOWER - UNII:7SCP4N87CI) CLEMATIS VITALBA FLOWER5 [hp_X]  in 30 mL
    ULMUS MINOR FLOWERING TWIG (UNII: J3O020I532) (ULMUS MINOR FLOWERING TWIG - UNII:J3O020I532) ULMUS MINOR FLOWERING TWIG5 [hp_X]  in 30 mL
    IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV) IMPATIENS GLANDULIFERA FLOWER5 [hp_X]  in 30 mL
    QUERCUS ROBUR FLOWER (UNII: ML644HED2V) (QUERCUS ROBUR FLOWER - UNII:ML644HED2V) QUERCUS ROBUR FLOWER5 [hp_X]  in 30 mL
    HELIANTHEMUM NUMMULARIUM FLOWER (UNII: 51BRR32WPP) (HELIANTHEMUM NUMMULARIUM FLOWER - UNII:51BRR32WPP) HELIANTHEMUM NUMMULARIUM FLOWER5 [hp_X]  in 30 mL
    AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M) AESCULUS HIPPOCASTANUM FLOWER5 [hp_X]  in 30 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED200 [hp_C]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81183-101-3030 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/26/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/26/2021
    Labeler - The Flower Remedy (117758477)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Flower Remedy117758477manufacture(81183-101)