FDA.reportPublic FDA data

Tobaccostat

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2023-08-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:22:08

Label at a glance#

ProductTobaccostat
Active ingredientAVENA SATIVA FLOWERING TOP, VALERIAN, CAPSICUM, PAULLINIA CUPANA SEED, LOBELIA INFLATA WHOLE, TOBACCO LEAF, CADMIUM SULFIDE, DIEFFENBACHIA SEGUINE, DAPHNE ODORA BARK, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, SPIGELIA ANTHELMIA WHOLE
Label structure9 sections

Dosage and administration

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(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:

OTC - PURPOSE SECTION

May temporarily relieve symptoms caused by tobacco intoxication, such as headache and dizziness.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

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.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve symptoms caused by tobacco intoxication, such as headache and dizziness.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579   800.869.8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

TOBACCOSTAT

1 fl. oz. (30 ml)

TobaccostatTobaccostat

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0458-12023-08-28C16284748780-1f386c649-a9ce-0266-e053-dadaa90a7c1aDRUG FACTS:
44911-0458-12023-01-30C16284748780-1f386c649-a9ce-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0458-1Tobaccostat30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0458TOBACCOSTAT (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 [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20230829_5f4ad1d8-4efb-4660-bab7-4fb05ff4f909.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-045844911-0458-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
VALERIANJWF5YAW3QWACTIB
CAPSICUM00UK7646FGACTIB
PAULLINIA CUPANA SEEDC21GE7524RACTIB
LOBELIA INFLATA WHOLE9PP1T3TC5UACTIB
TOBACCO LEAF6YR2608RSUACTIB
CADMIUM SULFIDE057EZR4Z7QACTIB
DIEFFENBACHIA SEGUINE01800C6E6BACTIB
DAPHNE ODORA BARKJSJ34YQJ5DACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
SPIGELIA ANTHELMIA WHOLEWYT05213GEACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TobaccostatAVENA SATIVA, VALERIANA OFFICINALIS, CAPSICUM ANNUUM, PAULLINIA SORBILIS, LOBELIA INFLATA, TABACUM, CADMIUM SULPHURATUM, CALADIUM SEGUINUM, DAPHNE INDICA, NUX VOMICA, PHOSPHORICUM ACIDUM, SPIGELIA ANTHELMIA, STAPHYSAGRIAEnergique, Inc.5f4ad1d8-4efb-4660-bab7-4fb05ff4f9092023-08-28WarningsExact identifier
ndc (package): 44911-0458-1
ndc (product): 44911-0458
ndc11 (package): 44911045801
spl id: ca5753fd-d64b-4c4e-9bdb-7082e91ffc9d
spl set id: 5f4ad1d8-4efb-4660-bab7-4fb05ff4f909

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.