Label: TOBACCOSTAT- avena sativa, valeriana officinalis, capsicum annuum, paullinia sorbilis, lobelia inflata, tabacum, cadmium sulphuratum, caladium seguinum, daphne indica, nux vomica, phosphoricum acidum, spigelia anthelmia, staphysagria liquid
- NDC Code(s): 44911-0458-1
- 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 August 28, 2023
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ACTIVE INGREDIENTS:
(in each drop): 12.43% of Cadmium Sulphuratum 12X, Caladium Seguinum 12X, Daphne Indica 12X, Lobelia Inflata 12X, Nux Vomica 12X, Phosphoricum Acidum 12X, Spigelia Anthelmia 12X, Staphysagria 12X; 0.10% of Avena Sativa 1X, Capsicum Annuum 3X, Lobelia Inflata 3X, Paullinia Sorbilis 3X, Tabacum 4X,Valeriana Officinalis 1X.
- INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
TOBACCOSTAT
avena sativa, valeriana officinalis, capsicum annuum, paullinia sorbilis, lobelia inflata, tabacum, cadmium sulphuratum, caladium seguinum, daphne indica, nux vomica, phosphoricum acidum, spigelia anthelmia, staphysagria liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44911-0458 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 LOBELIA INFLATA WHOLE (UNII: 9PP1T3TC5U) (LOBELIA INFLATA - UNII:9PP1T3TC5U) LOBELIA INFLATA WHOLE 3 [hp_X] in 1 mL TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF 4 [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 WHOLE (UNII: WYT05213GE) (SPIGELIA ANTHELMIA WHOLE - UNII:WYT05213GE) SPIGELIA ANTHELMIA WHOLE 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:44911-0458-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 06/15/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/15/2018 Labeler - Energique, Inc. (789886132) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(44911-0458) , api manufacture(44911-0458) , label(44911-0458) , pack(44911-0458)
