FDA.reportPublic FDA data

Quit Smoking Symptom Relief

Manufacturer
Boiron | Boiron, Inc.
Effective date
2023-07-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:21:35

Label at a glance#

ProductQuit Smoking Symptom Relief
Active ingredientLOBELIA INFLATA, STRYCHNOS NUX-VOMICA SEED
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients** (in each pellet)

Lobelia inflata 6C HPUS (0.44 mg) (contains less than 10 -12 mg lobeline alkaloids per pellet)

Nux vomica 30C HPUS (0.44 mg) (contains less than 10- 12 mg strychnine alkaloids per pellet)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Purpose*

Lobelia inflata 6C HPUS (0.44 mg) ... Relieves nausea associated with nicotine withdrawal

Nux vomica 30C HPUS (0.44 mg) ... Relieves irritability and digestive upset associated with nicotine withdrawal

INDICATIONS & USAGE SECTION

temporarily relieves symptoms associated with nicotine withdrawal such as:

  • nausea
  • irritability
  • digestive upset

OTC - STOP USE SECTION

Stop use and ask doctor if symptoms for more than 3 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions Retain this carton for full directions.

Adults 21 years of age and older:

Nausea: At the onset of symptoms, dissolve 5 pellets of Lobelia inflata 6C under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

Irritability or Digestive Upset: At the onset of symptoms, dissolve 5 pellets of Nux vomica 30C under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

INACTIVE INGREDIENT SECTION

lactose, sucrose

OTC - QUESTIONS SECTION

BoironUSA.com

Info@Boiron.com

1-800-BOIRON-1 (1-800-264-7661)

Made in France

Distributed by Boiron, Inc.

Newtown Square, PA 19073

SPL UNCLASSIFIED SECTION

do not use if glued end flaps are open or if pellet dispenser seal is broken

contains 0.25 g of sugar per dose

Turn tube upside down

Twist until 5 pellets are dispensed

Remove cap and pour pellets under the tongue

3 Tubes

Approx. 80 pellets each

Total 240 pellets

Meltaway pellets

Nausea Irritability Digestive Upset*

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9318-43Quit Smoking Symptom Relief80 in 1 TUBEPELLET801
0220-9318-43Quit Smoking Symptom Relief3 in 1 PACKAGEPELLET31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9318QUIT SMOKING SYMPTOM RELIEF (LOBELIA INFLATA WHOLE, STRYCHNOS NUX-VOMICA SEED) PELLET [BOIRON]1Current NDC, 2 package rows20230708_ffc34bc6-5de2-addb-e053-6294a90a25be.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-93180220-9318-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
LOBELIA INFLATA9PP1T3TC5UACTIB
SUCROSEC151H8M554IACT
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT

Source Document#

Source XML

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
Quit Smoking Symptom ReliefLOBELIA INFLATA WHOLE, STRYCHNOS NUX-VOMICA SEEDBoironffc34bc6-5de2-addb-e053-6294a90a25be2023-07-05Exact identifier
ndc (package): 0220-9318-43
ndc (product): 0220-9318
ndc11 (package): 00220931843
spl id: ffc34bc6-5de3-addb-e053-6294a90a25be
spl set id: ffc34bc6-5de2-addb-e053-6294a90a25be

Reported adverse events (FAERS/openFDA)#

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