Label: TOBACCOTOX- avena sativa, kali phosphoricum, cactus grandiflorus, eucalyptus globulus, lobelia inflata, daphne indica, mentholum, ignatia amara, nux vomica, staphysagria, tabacum, benzinum, naphthalinum liquid

  • NDC Code(s): 43857-0578-1
  • Packager: BioActive Nutritional, Inc.
  • 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 October 13, 2023

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  • ACTIVE INGREDIENTS:

    Avena Sativa 1X, Kali Phosphoricum 2X, Cactus Grandiflorus 3X, Eucalyptus Globulus 3X, Lobelia Inflata 3X, Daphne Indica 4X, Mentholum 4X, Ignatia Amara 12X, Nux Vomica 12X, Staphysagria 12X, Tabacum 12X, Benzinum 15X, 30X, Naphthalinum 15X, 30X

  • INDICATIONS:

    For temporary relief of nausea with headache, dry cough, and constriction of the chest.

  • WARNINGS:

    If pregnant or breast-feeding, ask a health care 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 cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN:

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

  • DIRECTIONS:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of nausea with headache, dry cough, and constriction of the chest.

  • INACTIVE INGREDIENTS:

    Demineralized water, 25% Ethanol

  • QUESTIONS:

    Distributed by:
    BioActive Nutritional, Inc.
    1803 N. Wickham Rd.
    Melbourne, FL 32935
    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    TOBACCOTOX

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Tobaccotox

  • INGREDIENTS AND APPEARANCE
    TOBACCOTOX 
    avena sativa, kali phosphoricum, cactus grandiflorus, eucalyptus globulus, lobelia inflata, daphne indica, mentholum, ignatia amara, nux vomica, staphysagria, tabacum, benzinum, naphthalinum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0578
    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
    DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE2 [hp_X]  in 1 mL
    SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK) SELENICEREUS GRANDIFLORUS STEM3 [hp_X]  in 1 mL
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6) EUCALYPTUS GLOBULUS LEAF3 [hp_X]  in 1 mL
    LOBELIA INFLATA WHOLE (UNII: 9PP1T3TC5U) (LOBELIA INFLATA - UNII:9PP1T3TC5U) LOBELIA INFLATA WHOLE3 [hp_X]  in 1 mL
    DAPHNE ODORA BARK (UNII: JSJ34YQJ5D) (DAPHNE ODORA BARK - UNII:JSJ34YQJ5D) DAPHNE ODORA BARK4 [hp_X]  in 1 mL
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM4 [hp_X]  in 1 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED12 [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
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED12 [hp_X]  in 1 mL
    TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF12 [hp_X]  in 1 mL
    BENZENE (UNII: J64922108F) (BENZENE - UNII:J64922108F) BENZENE15 [hp_X]  in 1 mL
    NAPHTHALENE (UNII: 2166IN72UN) (NAPHTHALENE - UNII:2166IN72UN) NAPHTHALENE15 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0578-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product02/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/18/2021
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0578) , api manufacture(43857-0578) , label(43857-0578) , pack(43857-0578)
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