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 
TRP Company

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Smokers Nicotine Relief

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.

Gum Base, Xylitol, Gum Arabic, Lactose, Natural flavor (Spearmint, Menthol), Artificial flavor, Maltitol, Isomalt, Stevia extract, Sorbitol, Shellac, Carnauba Wax

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.

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.

• 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.

• 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.

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

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.

Smokers Nicotine Relief

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:17312-035
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE) MILK THISTLE6 [hp_X]
ST. JOHN'S WORT (UNII: UFH8805FKA) (ST. JOHN'S WORT - UNII:UFH8805FKA) ST. JOHN'S WORT18 [hp_X]
WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73) WOOD CREOSOTE18 [hp_X]
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE18 [hp_X]
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP9 [hp_X]
LOBELIA INFLATA (UNII: 9PP1T3TC5U) (LOBELIA INFLATA - UNII:9PP1T3TC5U) LOBELIA INFLATA12 [hp_X]
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED18 [hp_X]
ASPIDOSPERMA QUEBRACHO-BLANCO BARK (UNII: 52B1340190) (ASPIDOSPERMA QUEBRACHO-BLANCO BARK - UNII:52B1340190) ASPIDOSPERMA QUEBRACHO-BLANCO BARK18 [hp_X]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN18 [hp_X]
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScorescore with uneven pieces
ShapeRECTANGLE ((pillow shape)) Size17mm
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17312-035-1612 in 1 CARTON03/23/2015
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/22/2015
Labeler - TRP Company (105185719)

Revised: 3/2015
Document Id: 11e8fe93-8f89-473a-e054-00144ff88e88
Set id: 11e8fe93-8f88-473a-e054-00144ff88e88
Version: 1
Effective Time: 20150322
 
TRP Company