Label: SMOKE FREE- dieffenbachia seguine, daphne odora bark, graphites, valerian tablet

  • NDC Code(s): 68466-0598-1
  • Packager: Schwabe Mexico, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL

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 December 22, 2020

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  • ACTIVE INGREDIENTS

    Caladium seguinum 6X

    Daphne indica 12X

    Graphites 12X

    Valerian officinalis 6X

  • INACTIVE INGREDIENT

    Cellulose

    Lactose monohydrate

    Magnesium stearate

  • Dosage & Administration:

    Directions: Sublingual medication. Place tablet under tongue and let dissolve.

    Tablets work best when taken at least 15 minutes before or after eating, brushing your teeth, or drinking anything except water.

    Adults: Stop smoking completely.

    Weeks 1 through 3, 1 tablet every hour.

    Weeks 4 through 6, 1 tablet every 2 hours, or as needed.

    Weeks 7 through 9, 1 tablet 4 times a day, or as needed.

  • Indications and Usage

    To reduce withdrawal symptoms, including cravings to smoke, withdrawal nerves, and increased appetite.

  • Purpose

    To reduce withdrawal symptoms, including cravings to smoke, withdrawal nerves, and increased appetite.

  • Warning

    Stop use and ask a doctor if condition does not improve in 4 weeks.

  • Pregnancy or Breast Feeding

    If pregnant or breast-feeding, ask a health professional before use.

  • Keep Out of Reach of Children

    Keep out of reach of children.

  • Overdose

    In case of overdose, seek medical help or contact a Poison Control Center immediately.

  • PRINCIPAL DISPLAY PANEL

    SmokeFree_21810598_04.jpg

  • INGREDIENTS AND APPEARANCE
    SMOKE FREE 
    dieffenbachia seguine, daphne odora bark, graphites, valerian tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68466-0598
    Route of AdministrationSUBLINGUAL, SUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIEFFENBACHIA SEGUINE (UNII: 01800C6E6B) (DIEFFENBACHIA SEGUINE - UNII:01800C6E6B) DIEFFENBACHIA SEGUINE6 [hp_X]
    DAPHNE ODORA BARK (UNII: JSJ34YQJ5D) (DAPHNE ODORA BARK - UNII:JSJ34YQJ5D) DAPHNE ODORA BARK12 [hp_X]
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE12 [hp_X]
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorwhite (B;T) Scoreno score
    ShapeROUND (BT) Size8mm
    FlavorImprint Code B;T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68466-0598-11 in 1 BOX06/01/201712/30/2025
    1100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/201712/30/2025
    Labeler - Schwabe Mexico, S.A. de C.V. (812805901)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe Mexico, S.A. de C.V.812805901manufacture(68466-0598)
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