Tobaccotox: Homeopathic Product Information

TOBACCOTOX- avena sativa flowering top, dibasic potassium phosphate, selenicereus grandiflorus stem, eucalyptus globulus leaf, lobelia inflata whole, daphne odora bark, menthol, unspecified form, strychnos ignatii seed, strychnos nux-vomica seed, delphinium staphisagria seed, tobacco leaf, benzene and naphthalene liquid
BioActive Nutritional, Inc.

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.

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:

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:

BIO Active Nutritional

TOBACCOTOX

HOMEOPATHIC

1 FL OZ (30 ml)

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 Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0578 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVENA SATIVA FLOWERING TOP (AVENA SATIVA FLOWERING TOP) AVENA SATIVA FLOWERING TOP 1 [hp_X] in 1 mL DIBASIC POTASSIUM PHOSPHATE (PHOSPHATE ION) DIBASIC POTASSIUM PHOSPHATE 2 [hp_X] in 1 mL SELENICEREUS GRANDIFLORUS STEM (SELENICEREUS GRANDIFLORUS STEM) SELENICEREUS GRANDIFLORUS STEM 3 [hp_X] in 1 mL EUCALYPTUS GLOBULUS LEAF (EUCALYPTUS GLOBULUS LEAF) EUCALYPTUS GLOBULUS LEAF 3 [hp_X] in 1 mL LOBELIA INFLATA WHOLE (LOBELIA INFLATA) LOBELIA INFLATA WHOLE 3 [hp_X] in 1 mL DAPHNE ODORA BARK (DAPHNE ODORA BARK) DAPHNE ODORA BARK 4 [hp_X] in 1 mL MENTHOL, UNSPECIFIED FORM (MENTHOL) MENTHOL, UNSPECIFIED FORM 4 [hp_X] in 1 mL STRYCHNOS IGNATII SEED (STRYCHNOS IGNATII SEED) STRYCHNOS IGNATII SEED 12 [hp_X] in 1 mL STRYCHNOS NUX-VOMICA SEED (STRYCHNOS NUX-VOMICA SEED) STRYCHNOS NUX-VOMICA SEED 12 [hp_X] in 1 mL DELPHINIUM STAPHISAGRIA SEED (DELPHINIUM STAPHISAGRIA SEED) DELPHINIUM STAPHISAGRIA SEED 12 [hp_X] in 1 mL TOBACCO LEAF (TOBACCO LEAF) TOBACCO LEAF 12 [hp_X] in 1 mL BENZENE (BENZENE) BENZENE 15 [hp_X] in 1 mL NAPHTHALENE (NAPHTHALENE) NAPHTHALENE 15 [hp_X] in 1 mL

Inactive Ingredients Ingredient Name Strength WATER ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43857-0578-1 30 mL in 1 BOTTLE, DROPPER None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/18/2021

Labeler — BioActive Nutritional, Inc. (624980496)

Registrant — Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Operations
Apotheca Company		844330915	manufacture (43857-0578), api manufacture (43857-0578), label (43857-0578), pack (43857-0578)

Revised: 02/2021 BioActive Nutritional, Inc.