TOBACCOTOX- avena sativa, kali phosphoricum, cactus grandiflorus, daphne indica, eucalyptol, lobelia inflata, mentholum, ignatia amara, nux vomica, staphysagria, tabacum, benzinum, naphtalinum, liquid
Apotheca Company

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.

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DRUG FACTS:

ACTIVE INGREDIENTS:

Avena sativa 1X, Kali Phosphoricum 2X, Cactus grandiflorus 3X, Daphne indica 3X, Eucalyptol 3X, Lobelia inflata 3X, Mentholum 3X, Ignatia amara 12X, Nux vomica 12X, Staphysagria 12X, Tabacum 12X, Benzinum 15X, 30X, Naphtalinum 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 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:

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

Melbourne, FL 32935

For Nutritional Information Write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE DISPLAY LABEL:

BioActive Homeopathic

TOBACCOTOX

1 FL OZ (30 ML)

Tobaccotox

TOBACCOTOX
avena sativa, kali phosphoricum, cactus grandiflorus, daphne indica, eucalyptol, lobelia inflata, mentholum, ignatia amara, nux vomica, staphysagria, tabacum, benzinum, naphtalinum, liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57520-0327
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	1 [hp_X] in 1 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	POTASSIUM PHOSPHATE, DIBASIC	2 [hp_X] in 1 mL
SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK)	SELENICEREUS GRANDIFLORUS STEM	3 [hp_X] in 1 mL
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	3 [hp_X] in 1 mL
LOBELIA INFLATA (UNII: 9PP1T3TC5U) (LOBELIA INFLATA - UNII:9PP1T3TC5U)	LOBELIA INFLATA	3 [hp_X] in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 [hp_X] in 1 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	12 [hp_X] in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	12 [hp_X] in 1 mL
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV)	DELPHINIUM STAPHISAGRIA SEED	12 [hp_X] in 1 mL
TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU)	TOBACCO LEAF	12 [hp_X] in 1 mL
BENZENE (UNII: J64922108F) (BENZENE - UNII:J64922108F)	BENZENE	30 [hp_X] in 1 mL
NAPHTHALENE (UNII: 2166IN72UN) (NAPHTHALENE - UNII:2166IN72UN)	NAPHTHALENE	30 [hp_X] in 1 mL
DAPHNE ODORA BARK (UNII: JSJ34YQJ5D) (DAPHNE ODORA BARK - UNII:JSJ34YQJ5D)	DAPHNE ODORA BARK	3 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57520-0327-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/11/2010	10/21/2016

Labeler - Apotheca Company (844330915)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(57520-0327) , api manufacture(57520-0327) , label(57520-0327) , pack(57520-0327)

Revised: 8/2015

Document Id: b2b16781-bc7d-4183-9cd0-64afa1e3e064

Set id: cbcee894-b0f2-40a8-8d26-59c4ea56fd1f

Version: 3

Effective Time: 20150806

Apotheca Company