Tobacco 2535p

Tobacco 2535p
SPL v2
SPL
SPL Set ID 9d399697-69dc-217d-e053-2a95a90a65e4
Route
ORAL
Published
Effective Date 2019-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tobacco Leaf (15 [hp_X]) Echinacea, Unspecified (6 [hp_X]) Taraxacum Officinale Valerian 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 Whole Arsenic Cation (3+) Benzoic Acid Berberis Vulgaris Root Bark Bryonia Alba Root Dieffenbachia Seguine Lytta Vesicatoria Ceanothus Americanus Leaf Chelidonium Majus
Inactive Ingredients
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-01-01

Description

Formulated for associated symptoms such as anxiety, cravings, irritability, labored breathing, cough, headaches and stress.

Purpose

Formulated for associated symptoms such as anxiety, cravings, irritability, labored breathing, cough, headaches and stress.


Medication Information

Purpose

Formulated for associated symptoms such as anxiety, cravings, irritability, labored breathing, cough, headaches and stress.

Description

Formulated for associated symptoms such as anxiety, cravings, irritability, labored breathing, cough, headaches and stress.

Package Label

Warnings Section

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Questions Section

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Otc Purpose Section

Formulated for associated symptoms such as anxiety, cravings, irritability, labored breathing, cough, headaches and stress.

Inactive Ingredient Section

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

Indications & Usage Section

Formulated for associated symptoms such as anxiety, cravings, irritability, labored breathing, cough, headaches and stress.

Dosage & Administration Section

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

Otc Active Ingredient Section

Equal parts of Echinacea 6x, Taraxacum 6x, Valeriana 6x, 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.

Otc Pregnancy Or Breast Feeding Section

If pregnant or breast-feeding, ask a doctor before use.

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)

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Questions Section (QUESTIONS SECTION)

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for associated symptoms such as anxiety, cravings, irritability, labored breathing, cough, headaches and stress.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for associated symptoms such as anxiety, cravings, irritability, labored breathing, cough, headaches and stress.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

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

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Echinacea 6x, Taraxacum 6x, Valeriana 6x, 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.

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

If pregnant or breast-feeding, ask a doctor before use.

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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