Label: SLEEP AID- aconitum napellus, aesculus hippocastanum, flos, arsenicum album, avena sativa, belladonna, camphora, cinchona officinalis, coffea cruda, cypripedium pubescens, hyoscyamus niger, kali phosphoricum, ignatia amara, passiflora incarnata, phosphorus, pulsatilla, valeriana officinalis. 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 December 7, 2022

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

  • Directions

    Initially, depress pump until
    primed.

    Spray one dose directly into
    mouth.

    Adults: 3 sprays 3 times per
    day.

    Children ages 6-12: 2 sprays 3
    times per day.

    Consult a physician for use in
    children under 6 years of age.

    Use additionally as needed, up
    to 6 times per day.

    Reference image:Sleep .jpg

  • OTHER SAFETY INFORMATION

    Other information

    Tamper resistant for your protection.

    Use only if safety seal is intact.

    Keep carton for complete drug facts and product information.

    Questions? Call 866.298.2740

    King Bio, Inc. 3 Westside Drive

    Asheville, NC 2806 USA

    FDA Reg. #1053442

    For latest product information and instructions: www.DrKings.com

    Reference image:Sleep .jpg

  • Inactive Ingredients

    Citrus Extract (ascorbic acid, citric acid, citrus aurantium amara fruit extract, citrus aurantium sinensis peel extract, citrus reticulata fruit extact, demineralized water, glycerin, lactic acid), Honeysuckle (Lonicera japonica), Polylysine, Purified Water, Shagbark Hickory (Carya Ovata) Bark Extract, Steviol (Steviol Glycosides).

    Reference image:Sleep .jpg

  • Active ingredients

    Equal volumes of each HPUS** ingredient in 10X, 30X, and 1LM
    potencies.

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

    HPUS indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

    Reference image:Sleep .jpg

  • Uses

    Uses for temporary relief of symptoms due to occasional
    sleeplessness: 

    Restlessness 

    Nervousness 

    Exhaustion 

    Excitability  

    Inability to fall or stay asleep 

    Worry

    as per various homeopathic materia medicas. Claims based
    on traditional homeopathic practice, not accepted medical
    evidence. These uses have not been evaluated by the FDA,
    and product has not been clinically tested.

    Reference image:Sleep .jpg

  • Warnings

    Stop use and consult a physician if symptoms worsen or
    persist for more than 7 days.

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

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center immediately.

    Reference image:Sleep .jpg

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center immediately.

    Reference image:Sleep .jpg

  • PURPOSE

    Equal volumes of each HPUS** ingredient in 10X, 30X, and 1LM
    potencies. 

    Aconitum napellus ..................................................fear, worry
    Aesculus hippocastanum, flos............................... heavy eyelids
    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
    Kali phosphoricum...................................................night terrors
    Ignatia amara ..................................................light sleep, worry
    Passiflora incarnata................................restlessness, wakefulness
    Phosphorus ...........................................................sleeplessness
    Pulsatilla .................................................irregular sleep patterns
    Valeriana officinalis..........................................tossing and turning


    **“HPUS” indicates the active ingredients are in the official
    Homeopathic Pharmacopeia of the United States.

    Reference image:Sleep .jpg

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    aconitum napellus, aesculus hippocastanum, flos, arsenicum album, avena sativa, belladonna, camphora, cinchona officinalis, coffea cruda, cypripedium pubescens, hyoscyamus niger, kali phosphoricum, ignatia amara, passiflora incarnata, phosphorus, pulsatilla, valeriana officinalis. liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-5638
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE10 [hp_X]  in 59 mL
    AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M) AESCULUS HIPPOCASTANUM FLOWER10 [hp_X]  in 59 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE10 [hp_X]  in 59 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP10 [hp_X]  in 59 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA10 [hp_X]  in 59 mL
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)10 [hp_X]  in 59 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK10 [hp_X]  in 59 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN10 [hp_X]  in 59 mL
    CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT - UNII:21Y9GZ1LZA) CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT10 [hp_X]  in 59 mL
    HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER10 [hp_X]  in 59 mL
    DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE10 [hp_X]  in 59 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED10 [hp_X]  in 59 mL
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP10 [hp_X]  in 59 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [hp_X]  in 59 mL
    PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS WHOLE10 [hp_X]  in 59 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    BENZYLPENICILLOYL POLYLYSINE (UNII: 76479814OY)  
    CARYA OVATA BARK (UNII: X765CF609L)  
    STEVIOL (UNII: 4741LYX6RT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-5638-21 in 1 CARTON08/16/2022
    159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/16/2022
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-5638) , api manufacture(57955-5638)