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

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

ACTIVE INGREDIENTS HPUS:

Caladium seguinum 6X

Daphne indica 12X

Graphites 12X

Valeriana officinalis 6X


INACTIVE INGREDIENT:

Lactose monohydrate

Magnesium stearate

Microcrystalline cellulose

Dosage and 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.

First 3 weeks, 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.

Warnings:

If condition does not improve in 4 weeks, consult a doctor.

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.

Ask the Doctor:

If condition does not improve in 4 weeks, consult a doctor.

Overdosage:

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

Purpose:

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

Package Label and Principal Display:

21810598_03-Smoke-Free.jpg21810598_03-Smoke-Free.jpg

21810598_03-Smoke-Free.jpg

21810598_03-Smoke-Free.jpg

SMOKE FREE 
dieffenbachia seguine, daphne odora bark, graphites, valerian tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-0598
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 BARK6 [hp_X]
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE12 [hp_X]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN6 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
Colorwhite (B;T) Scoreno score
ShapeROUND (BT) Size8mm
FlavorImprint Code B;T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-0598-21 in 1 BOX08/18/201101/20/2019
1100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/18/201101/20/2020
Labeler - Schwabe North America (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe Mexico, S.A. de C.V.812805901manufacture(53499-0598)

Revised: 1/2020
 
Schwabe North America