FDA.reportPublic FDA data

Tobacco Withdrawal

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:05:27

Label at a glance#

ProductTobacco Withdrawal
Active ingredientArsenic Trioxide, Benzoic Acid, Berberis Vulgaris Root Bark, Bryonia Alba Root, Dieffenbachia Seguine, Lytta Vesicatoria, Ceanothus Americanus Leaf, Chelidonium Majus, Chionanthus Virginicus Bark, Cinchona Officinalis Bark, Daphne Odora Bark, Strychnos Ignatii Seed, Iris Versicolor Root, Lycopodium Clavatum Spore, Nicotine, Strychnos Nux-vomica Seed, Toxicodendron Pubescens Leaf, Scutellaria Lateriflora, Tobacco Leaf, Echinacea, Unspecified, Taraxacum Officinale, Valerian
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Tobacco Withdrawal   Formulated for symptoms associated with tobacco use such as anxiety, cravings, irritability, tremors, stress, dyspnea, cough, excess mucus and headaches.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions:  ORAL USE ONLY - SHAKE WELL.  Adults, take 6 drops orally as needed or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Arsenicum alb. 15x, Benzoicum acidum 15x, Berber. vulg. 15x, Bryonia 15x, Caladium seguinum 15x, Cantharis 15x, Ceanothus 15x, Chelidonium majus 15x, Chionanthus virginica 15x, Cinchona 15x, Daphne indica 15x, Ignatia 15x, Iris versicolor 15x, Lycopodium 15x, Nicotinum 15x, Nux vom. 15x, Rhus toxicodendron 15x, Scutellaria lateriflora 15x, Tabacum 15x, Echinacea 3x, Taraxacum 3x, Valeriana 3x.

PURPOSE SECTION

ABUSE SECTION

Formulated for symptoms associated with tobacco use such as anxiety, cravings, irritability, tremors, stress, dyspnea, cough, excess mucus and headaches.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:  USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

QUESTIONS? SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256  

WARNINGS SECTION

Warning:  Do not use if tamper - evident seal is broken or missing.  Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.  Keep out of reach of children.  

PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days

KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label
Package Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-4538-12020-01-31C16284748780-19d75b9d0-fac3-f424-e053-dadaa90a57ceTobacco Withdrawal
55714-4538-22020-01-31C16284748780-19d75b9d0-fac3-f424-e053-dadaa90a57ceTobacco Withdrawal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4538-1Tobacco Withdrawal29.57 mL in 1 BOTTLE, GLASSLIQUID29.573
55714-4538-2Tobacco Withdrawal59.14 mL in 1 BOTTLE, GLASSLIQUID59.143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4538TOBACCO WITHDRAWAL (ARSENICUM ALB., BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DAPHNE INDICA, IGNATIA, IRIS VERSICOLOR, LYCOPODIUM, NICOTINUM, NUX VOM., RHUS TOXICODENDRON, SCUTELLARIA LATERIFLORA, TABACUM, ECHINACEA, TARAXACUM, VALERIANA) LIQUID [NEWTON LABORATORIES, INC.]3Legacy NDC, 2 package rows20140211_60c69d77-3cac-d1e7-5307-9423b79044b1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO3
Benzoic AcidACTIVE INGREDIENT8SKN0B0MIM3
Berberis Vulgaris Root BarkACTIVE INGREDIENT1TH8Q20J0U3
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B3
Ceanothus Americanus LeafACTIVE INGREDIENT25B1Y14T8N3
Chelidonium MajusACTIVE INGREDIENT7E889U5RNN3
Chionanthus Virginicus BarkACTIVE INGREDIENTS9Y4B22U2E3
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB3
Daphne Odora BarkACTIVE INGREDIENTJSJ34YQJ5D3
Dieffenbachia SeguineACTIVE INGREDIENT01800C6E6B3
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX3
Iris Versicolor RootACTIVE INGREDIENTX43D4L3DQC3
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4793
Lytta VesicatoriaACTIVE INGREDIENT3Q034RO3BT3
NicotineACTIVE INGREDIENT6M3C89ZY6R3
Scutellaria LaterifloraACTIVE INGREDIENT7BP4DH5PDC3
Strychnos Ignatii SeedACTIVE INGREDIENT1NM3M2487K3
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139193
Taraxacum OfficinaleACTIVE INGREDIENT39981FM3753
Tobacco LeafACTIVE INGREDIENT6YR2608RSU3
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A3
ValerianACTIVE INGREDIENTJWF5YAW3QW3
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV3
Benzoic AcidACTIVE MOIETY8SKN0B0MIM3
Berberis Vulgaris Root BarkACTIVE MOIETY1TH8Q20J0U3
Bryonia Alba RootACTIVE MOIETYT7J046YI2B3
Ceanothus Americanus LeafACTIVE MOIETY25B1Y14T8N3
Chelidonium MajusACTIVE MOIETY7E889U5RNN3
Chionanthus Virginicus BarkACTIVE MOIETYS9Y4B22U2E3
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB3
Daphne Odora BarkACTIVE MOIETYJSJ34YQJ5D3
Dieffenbachia SeguineACTIVE MOIETY01800C6E6B3
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX3
Iris Versicolor RootACTIVE MOIETYX43D4L3DQC3
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4793
Lytta VesicatoriaACTIVE MOIETY3Q034RO3BT3
NicotineACTIVE MOIETY6M3C89ZY6R3
Scutellaria LaterifloraACTIVE MOIETY7BP4DH5PDC3
Strychnos Ignatii SeedACTIVE MOIETY1NM3M2487K3
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139193
Taraxacum OfficinaleACTIVE MOIETY39981FM3753
Tobacco LeafACTIVE MOIETY6YR2608RSU3
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A3
ValerianACTIVE MOIETYJWF5YAW3QW3
AlcoholINACTIVE INGREDIENT3K9958V90M3

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-453855714-4538-1, 55714-4538-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
Arsenic TrioxideS7V92P67HOACTIB
Benzoic Acid8SKN0B0MIMACTIB
Berberis Vulgaris Root Bark1TH8Q20J0UACTIB
Bryonia Alba RootT7J046YI2BACTIB
Dieffenbachia Seguine01800C6E6BACTIB
Lytta Vesicatoria3Q034RO3BTACTIB
Ceanothus Americanus Leaf25B1Y14T8NACTIB
Chelidonium Majus7E889U5RNNACTIB
Chionanthus Virginicus BarkS9Y4B22U2EACTIB
Cinchona Officinalis BarkS003A158SBACTIB
Daphne Odora BarkJSJ34YQJ5DACTIB
Strychnos Ignatii Seed1NM3M2487KACTIB
Iris Versicolor RootX43D4L3DQCACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
Nicotine6M3C89ZY6RACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Toxicodendron Pubescens Leaf6IO182RP7AACTIB
Scutellaria Lateriflora7BP4DH5PDCACTIB
Tobacco Leaf6YR2608RSUACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
Taraxacum Officinale39981FM375ACTIB
ValerianJWF5YAW3QWACTIB
Alcohol3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates

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
8553afde-ca53-f656-5b7a-2a6e6e6a1b0760c69d77-3cac-d1e7-5307-9423b79044b12011-06-01WarningsExact identifier
spl id: 8553afde-ca53-f656-5b7a-2a6e6e6a1b07
spl set id: 60c69d77-3cac-d1e7-5307-9423b79044b1

Reported adverse events (FAERS/openFDA)#

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