Label: TOBACCOSTAT- avena sativa, valeriana officinalis, capsicum annuum, paullinia sorbilis, tabacum, lobelia inflata, cadmium sulphuratum, caladium seguinum, daphne indica, nux vomica, phosphoricum acidum, spigelia anthelmia, staphysagria liquid
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- NDC Code(s): 44911-0318-1
- Packager: Energique, 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 September 7, 2018
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENTS:
Avena Sativa 1X, Valeriana Officinalis 1X, Capsicum Annuum 3X, Paullinia Sorbilis 3X, Tabacum 3X, Lobelia Inflata 3X, 12X, Cadmium Sulphuratum 12X, Caladium Seguinum 12X, Daphne Indica 12X, Nux Vomica 12X, Phosphoricum Acidum 12X, Spigelia Anthelmia 12X, Staphysagria 12X.
Close - INDICATIONS:
For temporary relief of tobacco intoxication.**
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**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration. - 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.
Close - 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.
Close - 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.
Close - INDICATIONS:
For temporary relief of tobacco intoxication.**
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**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration. - INACTIVE INGREDIENTS:
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- PACKAGE LABEL DISPLAY:
- INGREDIENTS AND APPEARANCE
TOBACCOSTAT
avena sativa, valeriana officinalis, capsicum annuum, paullinia sorbilis, tabacum, lobelia inflata, cadmium sulphuratum, caladium seguinum, daphne indica, nux vomica, phosphoricum acidum, spigelia anthelmia, staphysagria liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44911-0318 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 1 [hp_X] in 1 mL VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 1 [hp_X] in 1 mL CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM 3 [hp_X] in 1 mL PAULLINIA CUPANA SEED (UNII: C21GE7524R) (PAULLINIA CUPANA SEED - UNII:C21GE7524R) PAULLINIA CUPANA SEED 3 [hp_X] in 1 mL TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF 3 [hp_X] in 1 mL LOBELIA INFLATA (UNII: 9PP1T3TC5U) (LOBELIA INFLATA - UNII:9PP1T3TC5U) LOBELIA INFLATA 3 [hp_X] in 1 mL CADMIUM SULFIDE (UNII: 057EZR4Z7Q) (CADMIUM CATION - UNII:T494FZ4G8G) CADMIUM SULFIDE 12 [hp_X] in 1 mL DIEFFENBACHIA SEGUINE (UNII: 01800C6E6B) (DIEFFENBACHIA SEGUINE - UNII:01800C6E6B) DIEFFENBACHIA SEGUINE 12 [hp_X] in 1 mL DAPHNE ODORA BARK (UNII: JSJ34YQJ5D) (DAPHNE ODORA BARK - UNII:JSJ34YQJ5D) DAPHNE ODORA BARK 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 PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID 12 [hp_X] in 1 mL SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE) SPIGELIA ANTHELMIA 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 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44911-0318-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 01/12/2016 02/17/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/12/2016 02/17/2021 Labeler - Energique, Inc. (789886132) Registrant - Apotheca Company (844330915) CloseEstablishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(44911-0318) , api manufacture(44911-0318) , label(44911-0318) , pack(44911-0318)
