Label: 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
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Contains inactivated NDC Code(s)
NDC Code(s): 17312-035-16 - Packager: TRP Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated March 22, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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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
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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.
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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.
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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
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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, chewingProduct 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)