Tobacco Withdrawal

Tobacco Withdrawal
SPL v1
SPL
SPL Set ID a5233f16-2f92-66fb-b144-5532c9a30d7c
Route
ORAL
Published
Effective Date 2012-04-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arsenic Cation (3+) (15 [hp_X]) Benzoic Acid (3 [hp_X]) 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
Inactive Ingredients
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01

Description

Tobacco Withdrawal   Formulated for symptoms associated with tobacco use such as anxiety, cravings, irritability, respiratory conditions and stress caused by abstinence.

Purpose

 Formulated for symptoms associated with tobacco use such as anxiety, cravings, irritability, respiratory conditions and stress caused by abstinence.


Medication Information

Purpose

 Formulated for symptoms associated with tobacco use such as anxiety, cravings, irritability, respiratory conditions and stress caused by abstinence.

Description

Tobacco Withdrawal   Formulated for symptoms associated with tobacco use such as anxiety, cravings, irritability, respiratory conditions and stress caused by abstinence.

Package Label

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.

Questions Section

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

Questions?  1.800.448.7256

Otc Purpose Section

 Formulated for symptoms associated with tobacco use such as anxiety, cravings, irritability, respiratory conditions and stress caused by abstinence.

Inactive Ingredient Section

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

Indications & Usage Section

Tobacco Withdrawal   Formulated for symptoms associated with tobacco use such as anxiety, cravings, irritability, respiratory conditions and stress caused by abstinence.

Dosage & Administration Section

Directions:  Adults, take 6 pellets orally as needed or as directed by a healthcare professional.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

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.

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

Otc Keep Out of Reach of Children Section

Keep out of reach of children.


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (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.

Questions Section (QUESTIONS SECTION)

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

Questions?  1.800.448.7256

Otc Purpose Section (OTC - PURPOSE SECTION)

 Formulated for symptoms associated with tobacco use such as anxiety, cravings, irritability, respiratory conditions and stress caused by abstinence.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Tobacco Withdrawal   Formulated for symptoms associated with tobacco use such as anxiety, cravings, irritability, respiratory conditions and stress caused by abstinence.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions:  Adults, take 6 pellets orally as needed or as directed by a healthcare professional.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc 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.

Otc 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

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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