SMOKE FREE- dieffenbachia seguine, daphne odora bark, graphites, valerian  tablet 
Schwabe North America, Inc.

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.

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Smoke Free Tablets

ACTIVE INGREDIENTS

Caladium seguinum 6X

Daphne indica 12X

Graphites 12X

Valerian officinalis 6X

INACTIVE INGREDIENT

Cellulose

Lactose monohydrate

Magnesium stearate

Dosage & Administation 

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.

Warnings

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.

Overdosage

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

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SMOKE FREE 
dieffenbachia seguine, daphne odora bark, graphites, valerian tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-9598
Route of AdministrationSUBLINGUAL
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:53499-9598-21 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 North America, Inc. (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe Mexico, S.A. de C.V.812805901manufacture(53499-9598)

Revised: 12/2020
Document Id: 8aee1c8e-4a86-444e-a771-0d410d914a66
Set id: 88df0e7e-6274-4169-85a3-6278ab669e32
Version: 5
Effective Time: 20201222
 
Schwabe North America, Inc.