FDA Label for Smokers Nicotine Relief
View Indications, Usage & Precautions
Smokers Nicotine Relief Product Label
The following document was submitted to the FDA by the labeler of this product Trp Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Adrenalinum HPUS 6x, 12x, 18x
Avena sativa HPUS 3x, 6x, 9x
Carduus marianus HPUS 3x, 6x
Hypericum HPUS 6x, 12x, 18x
Kreosotum HPUS 12x, 18x
Lobelia HPUS 6x, 12x
Nux vomica HPUS 6x, 12x, 18x
Quebracho HPUS 6x, 12x, 18x
Valeriana officinalis HPUS 6x, 12x, 18x
“HPUS” indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.
Inactive Ingredient
Gum Base, Xylitol, Gum Arabic, Lactose, Natural flavor (Spearmint, Menthol), Artificial flavor, Maltitol, Isomalt, Stevia extract, Sorbitol, Shellac, Carnauba Wax
Indications & Usage
According to homeopathic indications, these ingredients temporarily relieve and calm smoker’s nicotine related symptoms of: • cravings • withdrawal • irritability
• nicotine cleansing • cough/lung support after diagnosis by a physician.
*These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
Warnings
USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN AND UNDER THE SUPERVISION OF A PHYSICIAN.
• This product is intended to complement not replace standard smoking medical treatments. • Initial worsening of symptoms may occur.
Otc - Pregnancy Or Breast Feeding
• If you are pregnant or breast-feeding, ask a health care professional before use.
Otc - Keep Out Of Reach Of Children
• Keep out of reach of children under the age of 12.
Otc - Ask Doctor
Stop use and ask a doctor if: • New symptoms such as cough, congestion, allergies, and/or mouth, teeth or jaw problems occur.
Overdosage
• In case of overdose get medical help or contact a poison control center right away.
Instructions For Use
• Suitable for adults and children 12 years and above.
• For the first week before quitting, chew one piece of gum 6 times a day. • Do not smoke cigarettes after your quit date. • After your quit date for weeks 1 through 6, chew at least 9 pieces of gum per day or as often as needed instead of smoking a cigarette. • For weeks 7 through 12, chew at least 6 pieces of gum per day or as often as needed instead of smoking a cigarette. • After 12 weeks from your quit date, chew gum as needed. • Chew at least 10 minutes before or 10 minutes after eating. • Can use up to 20 pieces of gum per day. • Gum and Lozenges are interchangeable. • Homeopathic remedies may not be effective for everyone.
Other Safety Information
• There are no known contraindications. • Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects.
• Store in a cool dark location. • Smoker’s Nicotine ReliefTM Homeopathic Gum is a homeopathic dilution.
Otc - Purpose
Adrenalinum HPUS 6x, 12x, 18x................Stress, Fatigue
Avena sativa HPUS 3x, 6x, 9x...............Nicotine cleansing
Carduus marianus HPUS 3x, 6x....................Liver support
Hypericum HPUS 6x, 12x, 18x....Melancholy, Mood swings
Kreosotum HPUS 12x, 18x.....Mental Nicotine withdrawal
Lobelia HPUS 6x, 12x...........Physical Nicotine withdrawal
Nux vomica HPUS 6x, 12x, 18x...............Stress, Irritability
Quebracho HPUS 6x, 12x, 18x..........Cough / lung support
Valeriana officinalis HPUS 6x, 12x, 18x....Agitation, Anxiety
Dosage & Administration
For the first week before quitting, chew one piece of gum 6 times a day. Do not smoke cigarettes after your quit date. After your quit date for weeks 1 through 6, chew at least 9 pieces of gum per day or as often as needed instead of smoking a cigarette. For weeks 7 through 12, chew at least 6 pieces of gum per day or as often as needed instead of smoking a cigarette. After 12 weeks from your quit date, chew gum as needed. Chew at least 10 minutes before or 10 minutes after eating. Can use up to 20 pieces of gum per day.
Package Label.Principal Display Panel
* Please review the disclaimer below.