Tobacco Withdrawal

Manufacturer: Newton Laboratories, Inc.
Effective date: 2011-06-01
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:05:12

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

Contacts and useful links#

PhoneLabel contact1.800.448.7256

Websitewww.newtonlabs.net

www.newtonlabs.net

Label contents#

Full prescribing information#

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

Directions: Adults, take 6 pellets 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: Gluten-free, non-GMO, beet-derived sucrose pellets.

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139	Product name	3	20240506
e5a77e9c-c528-733a-173d-914a234c024b	Product name	5	20240506
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55714-4539-1	2020-01-31	C162847	48780-1	9d75b9cf-d4f6-f424-e053-dadaa90a57ce	Tobacco Withdrawal
55714-4539-2	2020-01-31	C162847	48780-1	9d75b9cf-d4f6-f424-e053-dadaa90a57ce	Tobacco Withdrawal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55714-4539-1	Tobacco Withdrawal	28.35 g in 1 BOTTLE, GLASS	PELLET	28.35		1
55714-4539-2	Tobacco Withdrawal	56.7 g in 1 BOTTLE, GLASS	PELLET	56.7		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55714-4539	TOBACCO 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) PELLET [NEWTON LABORATORIES, INC.]	1	Legacy NDC, 2 package rows	20131112_ebe43cf2-1c89-50a0-e5bc-504ebf4cea93.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Arsenic Trioxide	ACTIVE INGREDIENT	S7V92P67HO	1
Benzoic Acid	ACTIVE INGREDIENT	8SKN0B0MIM	1
Berberis Vulgaris Root Bark	ACTIVE INGREDIENT	1TH8Q20J0U	1
Bryonia Alba Root	ACTIVE INGREDIENT	T7J046YI2B	1
Ceanothus Americanus Leaf	ACTIVE INGREDIENT	25B1Y14T8N	1
Chelidonium Majus	ACTIVE INGREDIENT	7E889U5RNN	1
Chionanthus Virginicus Bark	ACTIVE INGREDIENT	S9Y4B22U2E	1
Cinchona Officinalis Bark	ACTIVE INGREDIENT	S003A158SB	1
Daphne Odora Bark	ACTIVE INGREDIENT	JSJ34YQJ5D	1
Dieffenbachia Seguine	ACTIVE INGREDIENT	01800C6E6B	1
Echinacea, Unspecified	ACTIVE INGREDIENT	4N9P6CC1DX	1
Iris Versicolor Root	ACTIVE INGREDIENT	X43D4L3DQC	1
Lycopodium Clavatum Spore	ACTIVE INGREDIENT	C88X29Y479	1
Lytta Vesicatoria	ACTIVE INGREDIENT	3Q034RO3BT	1
Nicotine	ACTIVE INGREDIENT	6M3C89ZY6R	1
Scutellaria Lateriflora	ACTIVE INGREDIENT	7BP4DH5PDC	1
Strychnos Ignatii Seed	ACTIVE INGREDIENT	1NM3M2487K	1
Strychnos Nux-vomica Seed	ACTIVE INGREDIENT	269XH13919	1
Taraxacum Officinale	ACTIVE INGREDIENT	39981FM375	1
Tobacco Leaf	ACTIVE INGREDIENT	6YR2608RSU	1
Toxicodendron Pubescens Leaf	ACTIVE INGREDIENT	6IO182RP7A	1
Valerian	ACTIVE INGREDIENT	JWF5YAW3QW	1
Arsenic Cation (3+)	ACTIVE MOIETY	C96613F5AV	1
Benzoic Acid	ACTIVE MOIETY	8SKN0B0MIM	1
Berberis Vulgaris Root Bark	ACTIVE MOIETY	1TH8Q20J0U	1
Bryonia Alba Root	ACTIVE MOIETY	T7J046YI2B	1
Ceanothus Americanus Leaf	ACTIVE MOIETY	25B1Y14T8N	1
Chelidonium Majus	ACTIVE MOIETY	7E889U5RNN	1
Chionanthus Virginicus Bark	ACTIVE MOIETY	S9Y4B22U2E	1
Cinchona Officinalis Bark	ACTIVE MOIETY	S003A158SB	1
Daphne Odora Bark	ACTIVE MOIETY	JSJ34YQJ5D	1
Dieffenbachia Seguine	ACTIVE MOIETY	01800C6E6B	1
Echinacea, Unspecified	ACTIVE MOIETY	4N9P6CC1DX	1
Iris Versicolor Root	ACTIVE MOIETY	X43D4L3DQC	1
Lycopodium Clavatum Spore	ACTIVE MOIETY	C88X29Y479	1
Lytta Vesicatoria	ACTIVE MOIETY	3Q034RO3BT	1
Nicotine	ACTIVE MOIETY	6M3C89ZY6R	1
Scutellaria Lateriflora	ACTIVE MOIETY	7BP4DH5PDC	1
Strychnos Ignatii Seed	ACTIVE MOIETY	1NM3M2487K	1
Strychnos Nux-vomica Seed	ACTIVE MOIETY	269XH13919	1
Taraxacum Officinale	ACTIVE MOIETY	39981FM375	1
Tobacco Leaf	ACTIVE MOIETY	6YR2608RSU	1
Toxicodendron Pubescens Leaf	ACTIVE MOIETY	6IO182RP7A	1
Valerian	ACTIVE MOIETY	JWF5YAW3QW	1
Sucrose	INACTIVE INGREDIENT	C151H8M554	1

Products#

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

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

Tobacco 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
Arsenic Trioxide
Arsenic Cation (3+)
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
Sucrose

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-4539	55714-4539-1, 55714-4539-2

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
Name	UNII	Kind
Arsenic Trioxide	S7V92P67HO	ACTIB
Benzoic Acid	8SKN0B0MIM	ACTIB
Berberis Vulgaris Root Bark	1TH8Q20J0U	ACTIB
Bryonia Alba Root	T7J046YI2B	ACTIB
Dieffenbachia Seguine	01800C6E6B	ACTIB
Lytta Vesicatoria	3Q034RO3BT	ACTIB
Ceanothus Americanus Leaf	25B1Y14T8N	ACTIB
Chelidonium Majus	7E889U5RNN	ACTIB
Chionanthus Virginicus Bark	S9Y4B22U2E	ACTIB
Cinchona Officinalis Bark	S003A158SB	ACTIB
Daphne Odora Bark	JSJ34YQJ5D	ACTIB
Strychnos Ignatii Seed	1NM3M2487K	ACTIB
Iris Versicolor Root	X43D4L3DQC	ACTIB
Lycopodium Clavatum Spore	C88X29Y479	ACTIB
Nicotine	6M3C89ZY6R	ACTIB
Strychnos Nux-vomica Seed	269XH13919	ACTIB
Toxicodendron Pubescens Leaf	6IO182RP7A	ACTIB
Scutellaria Lateriflora	7BP4DH5PDC	ACTIB
Tobacco Leaf	6YR2608RSU	ACTIB
Echinacea, Unspecified	4N9P6CC1DX	ACTIB
Taraxacum Officinale	39981FM375	ACTIB
Valerian	JWF5YAW3QW	ACTIB
Sucrose	C151H8M554	IACT

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 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sucrose	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED PELLETS / ORAL	59.8 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION / ORAL		31885 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / TRANSMUCOSAL		1255 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / SUBLINGUAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / RECTAL	35.42 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / INTRAVENOUS		1950 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	DROPS / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SUSPENSION / ORAL		40017 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, EMULSION / INTRAVENOUS		970 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / SUBCUTANEOUS	47.75 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / BUCCAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION/ DROPS / ORAL		3750 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fc6a6782-07d2-6831-d766-daad5d6e6d53			ebe43cf2-1c89-50a0-e5bc-504ebf4cea93	2011-06-01	Warnings	Exact identifier spl id: fc6a6782-07d2-6831-d766-daad5d6e6d53 spl set id: ebe43cf2-1c89-50a0-e5bc-504ebf4cea93

Reported adverse events (FAERS/openFDA)#

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