Tobacco Withdrawal
FDA Label NDC 55714-4539

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Newton Laboratories, Inc. for the product Tobacco Withdrawal (NDC 55714-4539). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding indications & usage section, dosage & administration section, active ingredient section, purpose section, inactive ingredient section, questions? section, warnings section, pregnancy or breast feeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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

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

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

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

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

Keep out of reach of children.

Package Label

Package Label (R070 P01)

Package Label (R070 P01)

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