TOBACCO- avena sativa, lobelia inflata, cactus grandiflorus, tabacum, gelsemium sempervirens, selenium metallicum, staphysagria, vanadium metallicum liquid
Deseret Biologicals, 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.

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Drug Facts:

ACTIVE INGREDIENTS:

Avena Sativa 1X, Lobelia Inflata 3X, Cactus Grandiflorus 4X, Tabacum 6X, Gelsemium Sempervirens 12X, Selenium Metallicum 12X, Staphysagria 12X, Vanadium Metallicum 12X.

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to tobacco toxicity including cough, tobacco stimulation or tranquilizing and nausea.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

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

If pregnant or breast-feeding, seek advice of a health professional before use.

Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

DIRECTIONS:

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol.

KEEP OUT OF REACH OF CHILDREN:

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

HOMEOPATHIC INDICATIONS:

For temporary relief of symptoms related to tobacco toxicity including cough, tobacco stimulation or tranquilizing and nausea.**

**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

QUESTIONS:

Dist. By: Deseret Biologicals, Inc.

469 W. Parkland Drive

Sandy, UT 84070 www.desbio.com

PACKAGE LABEL DISPLAY:

DESBIO

NDC 43742-0131-1

HOMEOPATHIC

TOBACCO

1 FL OZ (30 ml)

Tobacco

TOBACCO
avena sativa, lobelia inflata, cactus grandiflorus, tabacum, gelsemium sempervirens, selenium metallicum, staphysagria, vanadium metallicum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43742-0131
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
LOBELIA INFLATA (UNII: 9PP1T3TC5U) (LOBELIA INFLATA - UNII:9PP1T3TC5U)	LOBELIA INFLATA	3 [hp_X] in 1 mL
SELENICEREUS GRANDIFLORUS STEM (UNII: 7114SV0MYK) (SELENICEREUS GRANDIFLORUS STEM - UNII:7114SV0MYK)	SELENICEREUS GRANDIFLORUS STEM	4 [hp_X] in 1 mL
TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU)	TOBACCO LEAF	6 [hp_X] in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	12 [hp_X] in 1 mL
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B)	SELENIUM	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
VANADIUM (UNII: 00J9J9XKDE) (VANADIUM - UNII:00J9J9XKDE)	VANADIUM	12 [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:43742-0131-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	06/05/2017	07/13/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/20/2012	07/13/2022

Labeler - Deseret Biologicals, Inc. (940741853)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43742-0131) , api manufacture(43742-0131) , label(43742-0131) , pack(43742-0131)

Revised: 10/2018

Document Id: ace1a540-1b97-44d4-a07e-b2a60e4beb69

Set id: 461c8a67-9ca6-4b47-9b14-5ffc9c41064d

Version: 5

Effective Time: 20181019

Deseret Biologicals, Inc.