The following Structured Product Label (SPL) was submitted to the FDA by Living Well Remedies, Llc for the product Smoke Remedy (NDC 53852-1013). 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 otc - active ingredient, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients: Official HPUS: Avena sativa, Caladium seguinum, Calcarea phosphorica, Carbolicum acidum, Daphne indica, Eugenia jambosa, Ignatia amara, Kali phosphoricum, Lobelia inflata, Nicotinum, Nux vomica, Plantago major, Staphysagria, Tabacum. Equal volumes of each ingredient in 10C, 30C, 1LM potencies.
The letters "HPUS" indicate that the components in this product are officially monograped in the Homeopathic Pharmacopoeia of the United States.
Uses: Can help to stop smoking by reducing the craving and desire for tobacco smoke or chew. Helps prevent irritability, anxiety, nervousness and difficulty sleeping when quitting.*
*Claims based on traditional homeopathic practices, not accepted medical evidence.
Not FDA Evaluated
Warnings: Stop use and ask a doctor, if symptoms persist or worsen. If pregnant or breast-feeding, consult a health care professional before use.
Keep out of reach of children.
Directions: At each craving to smoke, spray 3 times into your mouth under your tongue. Avoid food or drink for about 5 after spraying. Take at least 3 to 6 times daily to reduce cravings. Take additional doses for cravings as needed. Stop taking Smoke Remedy when you no longer have the craving or desire to smoke.
Other Information: Do not use if safety seal is broken or missing. Store at room temperature away from heat and sunlight.
Inactive ingredients: Bio-Energetically enhanced pure water, citric acid, potassium sorbate.
Distributed by:
Living Well Remedies, LLC
P.O. Box 704, Franklin Lakes, NJ 07417
For more information visit
www.LivingWellRemedies.com
Made in the USA
LIVING WELL REMEDIES
SMOKE
Remedy®
To help stop smoking,
relieves cravings
and desire to smoke
Nature's Homeopathic Medicine
* Please review the disclaimer below.
