SMOKERS NICOTINE RELIEF- aspidosperma quebracho blanco, avena sativa, epinephrine, lobelia inflata, milk thistle, st johns wort, strychnos nux vomica seed, valerian, wood creosote gum, chewing

Smokers Nicotine Relief by

Drug Labeling and Warnings

Smokers Nicotine Relief by is a Homeopathic medication manufactured, distributed, or labeled by TRP Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

If you are pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children under the age of 12.

Stop use and ask a doctor if: New symptoms such as cough, congestion, allergies, and/or mouth, teeth or jaw problems occur.

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.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SMOKERS NICOTINE RELIEF 
aspidosperma quebracho blanco, avena sativa, epinephrine, lobelia inflata, milk thistle, st johns wort, strychnos nux vomica seed, valerian, wood creosote gum, chewing

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17312-035
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE)	MILK THISTLE	6 [hp_X]
ST. JOHN'S WORT (UNII: UFH8805FKA) (ST. JOHN'S WORT - UNII:UFH8805FKA)	ST. JOHN'S WORT	18 [hp_X]
WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73)	WOOD CREOSOTE	18 [hp_X]
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	18 [hp_X]
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	9 [hp_X]
LOBELIA INFLATA (UNII: 9PP1T3TC5U) (LOBELIA INFLATA - UNII:9PP1T3TC5U)	LOBELIA INFLATA	12 [hp_X]
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	18 [hp_X]
ASPIDOSPERMA QUEBRACHO-BLANCO BARK (UNII: 52B1340190) (ASPIDOSPERMA QUEBRACHO-BLANCO BARK - UNII:52B1340190)	ASPIDOSPERMA QUEBRACHO-BLANCO BARK	18 [hp_X]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	18 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
XYLITOL (UNII: VCQ006KQ1E)
MALTITOL (UNII: D65DG142WK)
ACACIA (UNII: 5C5403N26O)
LACTOSE (UNII: J2B2A4N98G)
SPEARMINT (UNII: J7I2T6IV1N)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
ISOMALT (UNII: S870P55O2W)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
SORBITOL (UNII: 506T60A25R)
SHELLAC (UNII: 46N107B71O)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	RECTANGLE ((pillow shape))	Size	17mm
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17312-035-16	12 in 1 CARTON	03/23/2015
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/22/2015

Labeler - TRP Company (105185719)