Label: SLEEP AID- aconitum nap, aesculus hipp, flos, arsenicum alb, avena, belladonna, camphora, cinchona, coffea cruda, cypripedium, hyoscyamus, ignatia, passiflora, pulsatilla, valeriana. 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 24, 2018

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  • ACTIVE INGREDIENT

    Drug Facts​__________________________________________________________________________________________________________

    HPUS active ingredients: Aconitum nap, Aesculus hipp, flos, Arsenicum alb, Avena, Belladonna, Camphora, Cinchona, Coffea cruda, Cypripedium, Hyoscyamus, Ignatia, Passiflora, Pulsatilla, Valerian.

    Equal volumes of each ingredient in 10X, 30X, 100X, 1LM, 2LM, 3LM, 5LM potencies.

  • INDICATIONS & USAGE

    Uses for relief of symptoms due to occasional sleeplessness: inability to fall or stay asleep, restless tossing, fear and worry, light sleeping, and overactive mind.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Bio-Energetically Enhanced™ pure water, Carya ovaa bark exract, citrus extract, Lonicera japonica (honeysuckle), polylysine, steviol glycosides.

  • WARNINGS

    Warnings

    • Stop use and ask your doctor if symptoms persist or worsen.
    • If pregnant or breast-feeding, take only on advice of a healthcare professional.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • DOSAGE & ADMINISTRATION

    Directions

    • Initially, depress pump until primed.
    • Spray one dose directly into mouth.
    • Adults 12 and up: 3 sprays 3 times per day.
    • Children 2-12: 2 sprays 3 times per day.
    • Children 2 mo.-2yr: 1 spray 3 times per day.
  • OTHER SAFETY INFORMATION

    Tamper resistant for your protection. Use only if safety seal is intact. This product has not been clinically tested.

  • PURPOSE

    Uses ​for relief of symptoms due to occasional sleeplessness:

    • inability to fall or stay asleep
    • restless tossing
    • fear and worry
    • light sleeping
    • overactive mind
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    aconitum nap, aesculus hipp, flos, arsenicum alb, avena, belladonna, camphora, cinchona, coffea cruda, cypripedium, hyoscyamus, ignatia, passiflora, pulsatilla, valeriana. liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-2641
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS59 [hp_X]  in 59 mL
    AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M) AESCULUS HIPPOCASTANUM FLOWER59 [hp_X]  in 59 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE59 [hp_X]  in 59 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP59 [hp_X]  in 59 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA59 [hp_X]  in 59 mL
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)59 [hp_X]  in 59 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK59 [hp_X]  in 59 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN59 [hp_X]  in 59 mL
    CYPRIPEDIUM PARVIFOLUM ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFOLUM ROOT - UNII:21Y9GZ1LZA) CYPRIPEDIUM PARVIFOLUM ROOT59 [hp_X]  in 59 mL
    HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER59 [hp_X]  in 59 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED59 [hp_X]  in 59 mL
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP59 [hp_X]  in 59 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS59 [hp_X]  in 59 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN59 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARYA OVATA BARK (UNII: X765CF609L)  
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    POLYEPSILON-LYSINE (4000 MW) (UNII: WB0M8X4TWR)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-2641-259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/24/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/24/2018
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-2641)
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