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

SMOKE FREE by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:

Caladium seguinum 6X

Daphne indica 12X

Graphites 12X

Valerian officinalis 6X

INACTIVE INGREDIENT

INACTIVE INGREDIENT:

Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose

DOSAGE & ADMINISTRATION

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.

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 & USAGE

Indications and Usage:

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

WARNINGS

Warnings:

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

PREGNANCY OR BREAST FEEDING

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:

Keep out of reach of children.

ASK DOCTOR

Ask the Doctor:

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

OVERDOSAGE

Overdosage:

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

PURPOSE

Purpose:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68466-0598
Route of Administration	SUBLINGUAL, 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	12 [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
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)

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: 68466-0598-1	1 in 1 BOX	06/01/2017
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		06/01/2017

Labeler - Schwabe Mexico, S.A. de C.V. (812805901)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico, S.A. de C.V.		812805901	manufacture(68466-0598)