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

  • 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 17, 2017

If you are a consumer or patient please visit this version.

  • 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

    Sorbitol, Xylitol, Natural flavor (Spearmint, Peppermint, Menthol), Lactose, Sucralose, Acesulfame Potassium, Calcium Stearate, Spirulina Extract, Riboflavin

  • 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.

  • INSTRUCTIONS FOR USE

    • Suitable for adults and children 12 years and above. • To use a lozenge, place it in your mouth, and let it dissolve slowly. Try not to chew or swallow the lozenge. • For the first week before quitting, use one lozenge 6 times a day. • Do not smoke cigarettes after your quit date. • After your quit date for weeks 1 through 6, use at least 9 lozenges per day or as often as needed instead of smoking a cigarette. • For weeks 7 through 12, use at least 6 lozenges per day or as often as needed instead of smoking a cigarette. • After 12 weeks from your quit date, use lozenges as needed. • Use the lozenge at least 10 minutes before or 10 minutes after eating. • Can use up to 20 lozenges per day. • Gum and lozenges are interchangeable. • Homeopathic remedies may not be effective for everyone.

  • 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.

  • OTHER SAFETY INFORMATION

    • There are no known contraindications. • Active ingredients are micro-diluted are therefore non-toxic with no known side effects. • Store in a cool dark location. • Smoker’s Nicotine ReliefTM Homeopathic Lozenges are a homeopathic dilution.

  • PURPOSE

    Active Ingredients 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

    To use a lozenge, place it in your mouth, and let it dissolve slowly. Try not to chew or swallow the lozenge. For the first week before quitting, use one lozenge 6 times a day.
    Do not smoke cigarettes after your quit date. After your quit date for weeks 1 through 6, use at least 9 lozenges per day or as often as needed instead of smoking a cigarette. For weeks 7 through 12, use at least 6 lozenges per day or as often as needed instead of smoking a cigarette. After 12 weeks from your quit date, use lozenges as needed.
    Use the lozenge at least 10 minutes before or 10 minutes after eating.
    Can use up to 20 lozenges per day.

  • PRINCIPAL DISPLAY PANEL

    ​Smokers Nicotine Relief

  • 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 lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17312-037
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP9 [hp_X]
    EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE18 [hp_X]
    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]
    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
    SORBITOL (UNII: 506T60A25R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SPEARMINT (UNII: J7I2T6IV1N)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    LACTOSE (UNII: J2B2A4N98G)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CALCIUM STEARATE (UNII: 776XM7047L)  
    SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)  
    RIBOFLAVIN (UNII: TLM2976OFR)  
    Product Characteristics
    Colorwhite, whiteScorescore with uneven pieces
    ShapeOVAL ((Lozenge)) Size10mm
    FlavorMINTImprint Code TRP
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17312-037-144 in 1 CARTON03/23/2015
    124 in 1 BOTTLE, PLASTIC; 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)