Label: TOBACCOSTAT- avena sativa, valeriana officinalis, capsicum annuum, paullinia sorbilis, lobelia inflata, tabacum, cadmium sulphuratum, caladium seguinum, daphne indica, nux vomica, phosphoricum acidum, spigelia anthelmia, staphysagria 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 June 15, 2018

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

  • ACTIVE INGREDIENTS:

    Avena Sativa 1X, Valeriana Officinalis 1X, Capsicum Annuum 3X, Paullinia Sorbilis 3X, Lobelia Inflata 3X, 12X, Tabacum 4X, Cadmium Sulphuratum 12X, Caladium Seguinum 12X, Daphne Indica 12X, Nux Vomica 12X, Phosphoricum Acidum 12X, Spigelia Anthelmia 12X, Staphysagria 12X.

  • INDICATIONS:

    May temporarily relieve symptoms caused by tobacco intoxication, such as headache and dizziness.**

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • WARNINGS:

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Do not use if tamper evident seal is broken or missing.

    Store in a cool, dry place.

  • 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 right away.

  • DIRECTIONS:

    Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    May temporarily relieve symptoms caused by tobacco intoxication, such as headache and dizziness.**

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • INACTIVE INGREDIENTS:

    Demineralized water, 20% Ethanol.

  • QUESTIONS:

    Dist. by Energique, Inc.

    201 Apple Blvd.

    Woodbine, IA 51579   800.868.8078

  • PACKAGE LABEL DISPLAY:

    ENERGIQUE

    SINCE 1987

    HOMEOPATHIC REMEDY

    TOBACCOSTAT

    1 fl. oz. (30 ml)

    Tobaccostat

  • INGREDIENTS AND APPEARANCE
    TOBACCOSTAT 
    avena sativa, valeriana officinalis, capsicum annuum, paullinia sorbilis, lobelia inflata, tabacum, cadmium sulphuratum, caladium seguinum, daphne indica, nux vomica, phosphoricum acidum, spigelia anthelmia, staphysagria liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0458
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP1 [hp_X]  in 1 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN1 [hp_X]  in 1 mL
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM3 [hp_X]  in 1 mL
    PAULLINIA CUPANA SEED (UNII: C21GE7524R) (PAULLINIA CUPANA SEED - UNII:C21GE7524R) PAULLINIA CUPANA SEED3 [hp_X]  in 1 mL
    LOBELIA INFLATA (UNII: 9PP1T3TC5U) (LOBELIA INFLATA - UNII:9PP1T3TC5U) LOBELIA INFLATA3 [hp_X]  in 1 mL
    TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF4 [hp_X]  in 1 mL
    CADMIUM SULFIDE (UNII: 057EZR4Z7Q) (CADMIUM CATION - UNII:T494FZ4G8G) CADMIUM SULFIDE12 [hp_X]  in 1 mL
    DIEFFENBACHIA SEGUINE (UNII: 01800C6E6B) (DIEFFENBACHIA SEGUINE - UNII:01800C6E6B) DIEFFENBACHIA SEGUINE12 [hp_X]  in 1 mL
    DAPHNE ODORA BARK (UNII: JSJ34YQJ5D) (DAPHNE ODORA BARK - UNII:JSJ34YQJ5D) DAPHNE ODORA BARK12 [hp_X]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_X]  in 1 mL
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID12 [hp_X]  in 1 mL
    SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE) SPIGELIA ANTHELMIA12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44911-0458-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product06/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/15/2018
    Labeler - Energique, Inc. (789886132)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(44911-0458) , api manufacture(44911-0458) , label(44911-0458) , pack(44911-0458)