SMOKE FREE by Schwabe North America, Inc / Schwabe Mexico, S.A. de C.V. Smoke Free

SMOKE FREE by

Drug Labeling and Warnings

SMOKE FREE by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe North America, Inc, Schwabe Mexico, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.jpg

SMOKE FREE 
dieffenbachia seguine, daphne odora bark, graphites, valerian tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-0598
Route of Administration	SUBLINGUAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIEFFENBACHIA SEGUINE (UNII: 01800C6E6B) (DIEFFENBACHIA SEGUINE - UNII:01800C6E6B)	DIEFFENBACHIA SEGUINE	6 [hp_X]
DAPHNE ODORA BARK (UNII: JSJ34YQJ5D) (DAPHNE ODORA BARK - UNII:JSJ34YQJ5D)	DAPHNE ODORA BARK	6 [hp_X]
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	12 [hp_X]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	white (B;T)	Score	no score
Shape	ROUND (BT)	Size	8mm
Flavor		Imprint Code	B;T
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-0598-2	1 in 1 BOX	08/18/2011	01/20/2019
1		100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/18/2011	01/20/2020

Labeler - Schwabe North America (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico, S.A. de C.V.		812805901	manufacture(53499-0598)

Revised: 1/2020

Document Id: 275ad5b7-ab5a-48dd-82fe-41eb556f0481

34390-5

Set id: 6fa20b06-180e-4529-8b4e-b27f923ce2d7

Version: 5

Effective Time: 20200120

 

Schwabe North America