Label: SMOKE CONTROL- aesculus hippocastanum, flos, agrimonia eupatoria, flos, caladium seguinum, capsicum annuum, daphne indica, eugenia jambosa, helianthus annuus, juglans regia, flos, kali phosphoricum, lobelia inflata, lonicera caprifolium, flos, nicotinum, nux vomica, plantago major, saccharum officinale, staphysagria, tabacum 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 November 21, 2016

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

  • ACTIVE INGREDIENT

    Drug Facts

    ____________________________________________________________________________________________________________________

    HPUS active ingredients: ​Aesculus hippocastanum, flos, Agrimonia eupatoria, flos, Caladium seguinum, Capsicum annuum, Daphne indica, Eugenia jambosa, Helianthus annuus, Juglans regia, flos, Kali phosphoricum, Lobelia inflata, Lonicera caprifolium, flos, Nicotinum, Nux vomica, Plantago major, Saccharum officinale, Staphysagria, Tabacum. Equal volumes of each ingredient in 10X, 30X, 100X, 1LM, 2LM, 3LM, 5LM potencies.

  • INDICATIONS & USAGE

    Uses for temporary relief of: tobacco cravings (smoke and chew), headache, shortness of breath, cough.

  • INACTIVE INGREDIENT

    Inactive ingredients: Bio-Energetically Enhanced pure water, citric acid, potassium sorbate.

  • 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.
    • Use additionally as needed, up to 6 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 temporary relief of:

    • tobacco cravings (smoke and chew)
    • headache
    • shortness of breath
    • cough

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SMOKE CONTROL 
    aesculus hippocastanum, flos, agrimonia eupatoria, flos, caladium seguinum, capsicum annuum, daphne indica, eugenia jambosa, helianthus annuus, juglans regia, flos, kali phosphoricum, lobelia inflata, lonicera caprifolium, flos, nicotinum, nux vomica, plantago major, saccharum officinale, staphysagria, tabacum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-3031
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M) AESCULUS HIPPOCASTANUM FLOWER10 [hp_X]  in 59 mL
    AGRIMONIA EUPATORIA FLOWER (UNII: 5811MI029U) (AGRIMONIA EUPATORIA FLOWER - UNII:5811MI029U) AGRIMONIA EUPATORIA FLOWER10 [hp_X]  in 59 mL
    DIEFFENBACHIA SEGUINE (UNII: 01800C6E6B) (DIEFFENBACHIA SEGUINE - UNII:01800C6E6B) DIEFFENBACHIA SEGUINE10 [hp_X]  in 59 mL
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM10 [hp_X]  in 59 mL
    DAPHNE ODORA BARK (UNII: JSJ34YQJ5D) (DAPHNE ODORA BARK - UNII:JSJ34YQJ5D) DAPHNE ODORA BARK10 [hp_X]  in 59 mL
    SYZYGIUM JAMBOS SEED (UNII: 97P0H45869) (SYZYGIUM JAMBOS SEED - UNII:97P0H45869) SYZYGIUM JAMBOS SEED10 [hp_X]  in 59 mL
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) (HELIANTHUS ANNUUS FLOWERING TOP - UNII:BKJ0J3D1BP) HELIANTHUS ANNUUS FLOWERING TOP10 [hp_X]  in 59 mL
    JUGLANS REGIA FLOWERING TOP (UNII: 3BA2N709NG) (JUGLANS REGIA FLOWERING TOP - UNII:3BA2N709NG) JUGLANS REGIA FLOWERING TOP10 [hp_X]  in 59 mL
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC10 [hp_X]  in 59 mL
    LOBELIA INFLATA (UNII: 9PP1T3TC5U) (LOBELIA INFLATA - UNII:9PP1T3TC5U) LOBELIA INFLATA10 [hp_X]  in 59 mL
    LONICERA CAPRIFOLIUM FLOWERING TOP (UNII: 1X0T378SXY) (LONICERA CAPRIFOLIUM FLOWERING TOP - UNII:1X0T378SXY) LONICERA CAPRIFOLIUM FLOWERING TOP10 [hp_X]  in 59 mL
    NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE10 [hp_X]  in 59 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED10 [hp_X]  in 59 mL
    PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR10 [hp_X]  in 59 mL
    SUCROSE (UNII: C151H8M554) (SUCROSE - UNII:C151H8M554) SUCROSE10 [hp_X]  in 59 mL
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED10 [hp_X]  in 59 mL
    TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-3031-259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/21/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/21/2014
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-3031)