Label: BEYOND INSOMNIA- cocculus, coffee tosta and nux vomica spray

  • 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 17, 2013

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  • Active Ingrdietns 

    Cocculus 30cH

    Coffee tosta 30cH

    nux vomica 30cH

  • Purpose 

    Promote sleep by calming the mind and body

  • Keep out of reach of children

    • Keep out of reach of children

  • Warnings

    Not intended for pregnant or lactating women
    Not to be taken by those with existing medical conditions, please consult your prior to use.

  • Inactive Ingredients:

    Purified Water, Ethyl Alcohol 15%

  • Directions 

    One pump spray under the tongue up to 6 times a day, or as needed

  • Usage

    Traditionally used to promote sleep by calming the mind and body

  • Product Label

    insomnia frontinsomnia back

  • INGREDIENTS AND APPEARANCE
    BEYOND INSOMNIA 
    cocculus, coffee tosta and nux vomica spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58214-456
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED30 [hp_C]  in 30 mL
    COFFEA ARABICA SEED, ROASTED (UNII: 9H58JRT35E) (COFFEA ARABICA SEED, ROASTED - UNII:9H58JRT35E) COFFEA ARABICA SEED, ROASTED30   in 30 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30   in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 30   in 30 mL
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58214-456-0130 mL in 1 PACKAGE; Type 0: Not a Combination Product06/11/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/10/2017
    Labeler - JMSP USA LLC (078770235)
    Registrant - JMSP USA LLC (078770235)
    Establishment
    NameAddressID/FEIBusiness Operations
    W Last CC567284153manufacture(58214-456)
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