Label: SLEEP AID - aconitum napellus, arsenic trioxide, avena sativa flowering top, atropa belladonna, camphor (natural), cinchona officinalis bark, arabica coffee bean, cypripedium parvifolum root, hyoscyamus niger, strychnos ignatii seed, passiflora incarnata flower, pulsatilla vulgaris, valerian and aesculus hippocastanum flower liquid 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 08/12

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

  • Active Ingredients

    Drug Facts

    HPUS active ingredients

    Equal volumes of each ingredient in 10X, 30X, and LM1 potencies

    Aconitum napellus, Arsenicum album, Avena sativa, Belladonna, Camphora, Cinchona officinalis, Coffea cruda, Cypripedium pubescens, Hyoscyamus niger, Ignatia amara, Passiflora incarnata, Pulsatilla, Valeriana officinalis. 

    HPUS Flower remedy

    Aesculus hippocastanum, flos


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  • Inactive Ingredient

    Bio-Energetically Enhanced taste free, pure water base


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  • Dosage and Administration

    Directions Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth.

    Adult dose: 3 pump sprays 3 times per day. Use additionally as needed.

    Children: 2-12 years 2 pump sprays 3 times per day. Use additionally as needed.


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  • Warnings

    If symptoms persist or worsen, or if pregnant or nursing, take only on advice of a healthcare professional. Keep out of reach of children.

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


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  • Purpose

    HPUS active ingredients                   Purpose

    Aconitum napellus...................................fear, worry

    Arsenicum album....................................anguish, fears

    Avena sativa..........................................nervous exhaustion

    Belladonna.............................................restlessness

    Camphora.............................................restless tossing

    Cinchona officinalis.................................anxious dreams, early waking

    Coffea cruda.........................................nervous excitability

    Cypripedium pubescens.........................wakefulness

    Hyoscyamus niger.................................inability to fall asleep

    Ignatia amara.........................................light sleep, worry

    Passiflora incarnata................................restlessness, wakefulness

    Pulsatilla................................................irregular sleep patterns

    Valeriana officinalis................................tossing and turning

    HPUS flower remedy

    Aesculus hippocastanum, flos................calming


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  • Indications and usage

    Uses: temporarily relieves symptoms due to occasional sleeplessness:

    • restlessness
    • nervousness
    • exhaustion
    • excitability
    • inability to fall or stay asleep
    • worry
    as per various homeopathic Materia Medicas


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  • KEEP OUT OF REACH OF CHILDREN

    Warnings:

    Keep out of reach of children.


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  • PRINCIPAL DISPLAY PANEL

    Image of carton

    King Bio Inc.

    3 Westside Drive

    Asheville, NC 28806

    www.kingbio.com

    Questions? Call 800.543.3245

    Safe and Natural Homeopathic Spray


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  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    aconitum napellus, arsenicum album, avena sativa, belladonna, camphora, cinchona officinalis, coffea cruda, cypripedium pubescens, hyoscyamus niger, ignatia amara, passiflora incarnata, pulsatilla, valeriana officinalis,aesculus hippocastanum, flos liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57955-5639
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 10 [hp_X]  in 59 mL
    ARSENIC TRIOXIDE (ARSENIC CATION (3+)) ARSENIC TRIOXIDE 10 [hp_X]  in 59 mL
    AVENA SATIVA FLOWERING TOP (AVENA SATIVA FLOWERING TOP) AVENA SATIVA FLOWERING TOP 10 [hp_X]  in 59 mL
    ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 10 [hp_X]  in 59 mL
    CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL) 10 [hp_X]  in 59 mL
    CINCHONA OFFICINALIS BARK (CINCHONA OFFICINALIS BARK) CINCHONA OFFICINALIS BARK 10 [hp_X]  in 59 mL
    ARABICA COFFEE BEAN (ARABICA COFFEE BEAN) ARABICA COFFEE BEAN 10 [hp_X]  in 59 mL
    CYPRIPEDIUM PARVIFOLUM ROOT (CYPRIPEDIUM PARVIFOLUM ROOT) CYPRIPEDIUM PARVIFOLUM ROOT 10 [hp_X]  in 59 mL
    HYOSCYAMUS NIGER (HYOSCYAMUS NIGER) HYOSCYAMUS NIGER 10 [hp_X]  in 59 mL
    STRYCHNOS IGNATII SEED (STRYCHNOS IGNATII SEED) STRYCHNOS IGNATII SEED 10 [hp_X]  in 59 mL
    PASSIFLORA INCARNATA FLOWER (PASSIFLORA INCARNATA FLOWER) PASSIFLORA INCARNATA FLOWER 10 [hp_X]  in 59 mL
    PULSATILLA VULGARIS (PULSATILLA VULGARIS) PULSATILLA VULGARIS 10 [hp_X]  in 59 mL
    VALERIAN (VALERIAN) VALERIAN 10 [hp_X]  in 59 mL
    AESCULUS HIPPOCASTANUM FLOWER (AESCULUS HIPPOCASTANUM FLOWER) AESCULUS HIPPOCASTANUM FLOWER 10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57955-5639-2 1 in 1 BOX
    1 59 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 07/15/2011
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    Name Address ID/FEI Business Operations
    King Bio Inc. 617901350 api manufacture(57955-5639)
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