Label: QUIT SMOKING SYMPTOM RELIEF- lobelia inflata whole, strychnos nux-vomica seed pellet

  • 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 July 5, 2023

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

  • ACTIVE INGREDIENT

    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.

  • PURPOSE

    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

    temporarily relieves symptoms associated with nicotine withdrawal such as:

    • nausea
    • irritability
    • digestive upset
  • WARNINGS

  • STOP USE

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

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    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

    lactose, sucrose

  • QUESTIONS

    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.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    QUIT SMOKING SYMPTOM RELIEF 
    lobelia inflata whole, strychnos nux-vomica seed pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9318
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LOBELIA INFLATA (UNII: 9PP1T3TC5U) (LOBELIA INFLATA - UNII:9PP1T3TC5U) LOBELIA INFLATA6 [hp_C]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScore    
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9318-433 in 1 PACKAGE07/05/2023
    180 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/05/2023
    Labeler - Boiron (282560473)
    Registrant - Boiron, Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9318)