Label: HARMONY SLUMBER- avena sativa, chamomilla, cypripedium pubescens, daphne indica, humulus lupulus, hyoscyamus niger, kali bromatum, kali phosphoricum, lithium muriaticum, passiflora incarnata, scutellaria lateriflora, stramonium, succinum, sumbul, valeriana officinalis, xanthoxylum fraxineum, ferrum phosphoricum, lecithin, manganum phosphoricum, arsenicum album, coffea cruda, ignatia amara, nux moschata, agaricus muscarius, belladonna, cocculus indicus, helleborus niger, jequirity, melissa officinalis, viburnum opulus 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 March 4, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Avena sativa, Chamomilla, Cypripedium pubescens, Daphne indica, Humulus lupulus, Hyoscyamus niger, Kali bromatum, Kali phosphoricum, Lithium muriaticum, Passiflora incarnata, Scutellaria lateriflora, Stramonium, Succinum, Sumbul, Valeriana officinalis, Xanthoxylum fraxineum at a 6X potency. Ferrum phosphoricum, Lecithin, Manganum phosphoricum at a 8X potency. Arsenicum album, Coffea cruda, Ignatia amara at a 30X potency. Nux moschata at 4C potency. Agaricus muscarius, Belladonna, Cocculus indicus, Helleborus niger, Jequirity, Melissa officinalis, Viburnum opulus at a 6C potency. Equal volumes of each ingredient.

  • INACTIVE INGREDIENT

    Inactive Ingredient: Energetic mineralized water (magnesium, potassium). ethanol 13%(v/v). glycerin 8%(v/v).

  • WARNINGS

    Warnings:If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Stop use and ask your doctor if symptoms persist or worsen. Store in a cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OTHER SAFETY INFORMATION

    Other information: Tamper resistant for your protection. Use only if safety seal is intact.

    *This product has not been clinically tested. Homeopathic provings for each HPUS ingredient are found in various materia medicas referenced in the FDA Compliance Policy Guide.

    To reorder please visit: www.EnergeticElixirs.com

    Dist. by:

    Life Harmony Energies, LLC

    1905 Lehigh St. Boulder, CO 80305

    service@lifeharmonyenergies.com

  • PURPOSE

    Indications: ​A natural aid for falling asleep and sleeping through the night. Helps to restore and balance sleep cycle.

  • DOSAGE & ADMINISTRATION

    Directions: Adults and children over 12 years of age use 4 to 8 sprays orally at bedtime. May take another dose during the night upon waking prematurely.

  • INDICATIONS & USAGE

    Indications: ​•​​A natural aid for falling asleep and sleeping through the night. •Helps to restore and balance sleep cycle.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HARMONY SLUMBER 
    avena sativa, chamomilla, cypripedium pubescens, daphne indica, humulus lupulus, hyoscyamus niger, kali bromatum, kali phosphoricum, lithium muriaticum, passiflora incarnata, scutellaria lateriflora, stramonium, succinum, sumbul, valeriana officinalis, xanthoxylum fraxineum, ferrum phosphoricum, lecithin, manganum phosphoricum, arsenicum album, coffea cruda, ignatia amara, nux moschata, agaricus muscarius, belladonna, cocculus indicus, helleborus niger, jequirity, melissa officinalis, viburnum opulus liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69631-0001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP6 [hp_X]  in 60 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA6 [hp_X]  in 60 mL
    CYPRIPEDIUM PARVIFOLUM ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFOLUM ROOT - UNII:21Y9GZ1LZA) CYPRIPEDIUM PARVIFOLUM ROOT6 [hp_X]  in 60 mL
    DAPHNE ODORA BARK (UNII: JSJ34YQJ5D) (DAPHNE ODORA BARK - UNII:JSJ34YQJ5D) DAPHNE ODORA BARK6 [hp_X]  in 60 mL
    HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS6 [hp_X]  in 60 mL
    HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER6 [hp_X]  in 60 mL
    POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE6 [hp_X]  in 60 mL
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC6 [hp_X]  in 60 mL
    LITHIUM CHLORIDE (UNII: G4962QA067) (LITHIUM CATION - UNII:8H8Z5UER66) LITHIUM CHLORIDE6 [hp_X]  in 60 mL
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP6 [hp_X]  in 60 mL
    SCUTELLARIA LATERIFLORA (UNII: 7BP4DH5PDC) (SCUTELLARIA LATERIFLORA - UNII:7BP4DH5PDC) SCUTELLARIA LATERIFLORA6 [hp_X]  in 60 mL
    DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM6 [hp_X]  in 60 mL
    AMBER (UNII: 70J9Z0J26P) (AMBER - UNII:70J9Z0J26P) AMBER6 [hp_X]  in 60 mL
    FERULA SUMBUL ROOT (UNII: GLA4808EHQ) (FERULA SUMBUL ROOT - UNII:GLA4808EHQ) FERULA SUMBUL ROOT6 [hp_X]  in 60 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN6 [hp_X]  in 60 mL
    ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T) (ZANTHOXYLUM AMERICANUM BARK - UNII:A4KL1HMZ7T) ZANTHOXYLUM AMERICANUM BARK6 [hp_X]  in 60 mL
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE8 [hp_X]  in 60 mL
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) (EGG PHOSPHOLIPIDS - UNII:1Z74184RGV) EGG PHOSPHOLIPIDS8 [hp_X]  in 60 mL
    MANGANESE PHOSPHATE, DIBASIC (UNII: VZ3U1H7Q5B) (MANGANESE CATION (2+) - UNII:H6EP7W5457) MANGANESE PHOSPHATE, DIBASIC8 [hp_X]  in 60 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE30 [hp_X]  in 60 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN30 [hp_X]  in 60 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED30 [hp_X]  in 60 mL
    NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG4 [hp_C]  in 60 mL
    AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037) AMANITA MUSCARIA FRUITING BODY6 [hp_C]  in 60 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_C]  in 60 mL
    ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED6 [hp_C]  in 60 mL
    HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER ROOT6 [hp_C]  in 60 mL
    ABRUS PRECATORIUS SEED (UNII: 3OM8I6L7CD) (ABRUS PRECATORIUS SEED - UNII:3OM8I6L7CD) ABRUS PRECATORIUS SEED6 [hp_C]  in 60 mL
    MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N) MELISSA OFFICINALIS6 [hp_C]  in 60 mL
    VIBURNUM OPULUS BARK (UNII: T1UG6H6805) (VIBURNUM OPULUS BARK - UNII:T1UG6H6805) VIBURNUM OPULUS BARK6 [hp_C]  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM (UNII: I38ZP9992A)  
    POTASSIUM (UNII: RWP5GA015D)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69631-0001-260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/08/2015
    Labeler - Life Harmony Energies, LLC. (079705635)
    Registrant - Life Harmony Energies, LLC. (079705635)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(69631-0001)
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