Label: BEYOND NICOTINE- kali sulph, nicotinum , plantago and tabacum 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 June 12, 2017

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  • Active Ingrdietns 

    Kali Sulph 6x

    Nicotinum 9cH

    Plantago 9cH

    Tabacum 9cH

  • Purpose of ingredients:

    Traditionally used to alleviate craving for and discomfort from smoking or vaping.

  • 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 physician prior to use.
  • Indications and Usage:

    A pump spray under the tongue up to 10 when you would normally have a cigarette. Reduce to 6 times a day after a week or as needed

  • Inactive Ingredients:

    Purified Water and Ethyl Alcohol

  • Directions 

    One pump spray under the tongue up to 10 times a day or when you would normally have a cigarette. Reduce to 6 times a day after a week or as needed

  • Product Label

    nicotin front

    ncotine back

  • INGREDIENTS AND APPEARANCE
    BEYOND NICOTINE 
    kali sulph, nicotinum , plantago and tabacum spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58214-789
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM SULFATE (UNII: 1K573LC5TV) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM SULFATE6 [hp_X]  in 30 mL
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE9   in 30 mL
    PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR9   in 30 mL
    TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF9   in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58214-789-0130 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(58214-789)
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