Smokers Nicotine Relief

Manufacturer
TRP Company
Effective date
2017-03-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:16:57

Label at a glance#

ProductSmokers Nicotine Relief
Active ingredientAVENA SATIVA FLOWERING TOP, EPINEPHRINE, MILK THISTLE, ST. JOHN'S WORT, WOOD CREOSOTE, LOBELIA INFLATA, STRYCHNOS NUX-VOMICA SEED, ASPIDOSPERMA QUEBRACHO-BLANCO BARK, VALERIAN
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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 SECTION

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

INDICATIONS & USAGE SECTION

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 SECTION

• 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 SECTION

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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - ASK DOCTOR SECTION

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.

OTC - PURPOSE SECTION

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 SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​Smokers Nicotine Relief​Smokers Nicotine Relief

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17312-037-142024-11-22C16284748780-19d75b9d1-05ca-f424-e053-dadaa90a57ceSmokers Nicotine Relief
17312-037-142020-01-31C16284748780-19d75b9d1-05ca-f424-e053-dadaa90a57ceSmokers Nicotine Relief

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASPIDOSPERMA QUEBRACHO-BLANCO BARKACTIVE INGREDIENT52B13401901
AVENA SATIVA FLOWERING TOPACTIVE INGREDIENTMA9CQJ3F7F1
EPINEPHRINEACTIVE INGREDIENTYKH834O4BH1
LOBELIA INFLATAACTIVE INGREDIENT9PP1T3TC5U1
MILK THISTLEACTIVE INGREDIENTU946SH95EE1
ST. JOHN'S WORTACTIVE INGREDIENTUFH8805FKA1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139191
VALERIANACTIVE INGREDIENTJWF5YAW3QW1
WOOD CREOSOTEACTIVE INGREDIENT3JYG22FD731
ASPIDOSPERMA QUEBRACHO-BLANCO BARKACTIVE MOIETY52B13401901
AVENA SATIVA FLOWERING TOPACTIVE MOIETYMA9CQJ3F7F1
EPINEPHRINEACTIVE MOIETYYKH834O4BH1
LOBELIA INFLATAACTIVE MOIETY9PP1T3TC5U1
MILK THISTLEACTIVE MOIETYU946SH95EE1
ST. JOHN'S WORTACTIVE MOIETYUFH8805FKA1
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139191
VALERIANACTIVE MOIETYJWF5YAW3QW1
WOOD CREOSOTEACTIVE MOIETY3JYG22FD731
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G91
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047L1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G1
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3A1
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2B1
RIBOFLAVININACTIVE INGREDIENTTLM2976OFR1
SORBITOLINACTIVE INGREDIENT506T60A25R1
SPEARMINTINACTIVE INGREDIENTJ7I2T6IV1N1
SPIRULINA MAXIMAINACTIVE INGREDIENT9K7IG15M0Q1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD41
XYLITOLINACTIVE INGREDIENTVCQ006KQ1E1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17312-03717312-037-14

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 172 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LACTOSELACTOSEJ2B2A4N98GSOLUTION / ORAL1682 mg/15mlExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, DELAYED RELEASE / ORAL160 mgExact identifier — unii candidate
36 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET / ORAL337.28 mgExact identifier — unii candidate
44 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ADROPS / NASAL40.32 mgExact identifier — unii candidate
24 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESUSPENSION, EXTENDED RELEASE / ORAL9000 mgExact identifier — unii candidate
12 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ATABLET, ORALLY DISINTEGRATING / ORAL14 mgExact identifier — unii candidate
24 equally ranked IID candidates
SPEARMINTSPEARMINTJ7I2T6IV1NSOLUTION / ORAL0.04 ml/5mlExact identifier — unii candidate
4 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET / ORAL45 mgExact identifier — unii candidate
22 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, COATED / ORAL332.05 mgExact identifier — unii candidate
36 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE, DENTIFRICE / DENTAL14 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
CALCIUM STEARATECALCIUM STEARATE776XM7047LTABLET / ORAL280 mgExact identifier — unii candidate
12 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
RIBOFLAVINRIBOFLAVINTLM2976OFRTABLET / ORAL0.03 mgExact identifier — unii candidate
LACTOSELACTOSEJ2B2A4N98GINJECTION, SOLUTION / INTRAVENOUS0.45 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRALESIONAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
22 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, COATED PELLETS / ORAL135.2 mgExact identifier — unii candidate
36 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, FOR SUSPENSION / ORAL65 mgExact identifier — unii candidate
22 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3APASTE, DENTIFRICE / DENTAL4.7 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3AAEROSOL, METERED / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9SOLUTION / DENTAL0.12 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
ACESULFAME POTASSIUMACESULFAME POTASSIUM23OV73Q5G9TROCHE / ORAL26 mgExact identifier — unii candidate
17 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3AGUM, CHEWING / BUCCAL89 mgExact identifier — unii candidate
24 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii candidate
44 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4POWDER, FOR SOLUTION / ORAL414 mgExact identifier — unii candidate
22 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RELIXIR / ORAL833.3 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii candidate
44 equally ranked IID candidates
CALCIUM STEARATECALCIUM STEARATE776XM7047LTABLET, COATED / ORAL12.2 mgExact identifier — unii candidate
12 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET / SUBLINGUAL50.5 mgExact identifier — unii candidate
44 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii candidate
22 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ACONCENTRATE / ORAL0.05 mg/5mlExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3AJELLY / NASAL32.5 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3AMOUTHWASH / BUCCAL0.15 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE / RESPIRATORY (INHALATION)44.4 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCREAM / VAGINAL3 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
CALCIUM STEARATECALCIUM STEARATE776XM7047LTABLET, CHEWABLE / ORAL240 mgExact identifier — unii candidate
12 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GGRANULE, FOR SUSPENSION / ORAL512.5 mg/5mlExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS133 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, EXTENDED RELEASE / ORAL400 mgExact identifier — unii candidate
36 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4LOZENGE / ORAL115 mgExact identifier — unii candidate
22 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ACAPSULE / ORAL0.87 mgExact identifier — unii candidate
24 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, FILM COATED, EXTENDED RELEASE / ORAL620 mgExact identifier — unii candidate
36 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ATABLET / ORAL0.58 mgExact identifier — unii candidate
24 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RAEROSOL, FOAM / TOPICAL4.95 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRA-ARTICULAR45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRAMUSCULARNAExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION, CONCENTRATE / ORAL300 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR133 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / SUBLINGUAL352 mgExact identifier — unii candidate
36 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ASOLUTION, CONCENTRATE / ORAL0.5 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, FILM COATED / ORAL590 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ADROPS / OPHTHALMICNAExact identifier — unii candidate
24 equally ranked IID candidates
SUCRALOSESUCRALOSE96K6UQ3ZD4GUM, CHEWING / BUCCAL70 mgExact identifier — unii candidate
22 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / RECTAL20 mgExact identifier — unii candidate
36 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9c5a1b71-2df1-6752-e053-2a95a90abbc611eca6c7-03f0-26f0-e054-00144ff88e882024-01-17WarningsExact identifier
spl set id: 11eca6c7-03f0-26f0-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.