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  5. Label Information: Smoke Free

FDA Label for Smoke Free

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. INACTIVE INGREDIENT
    3. DOSAGE & ADMINISTRATION
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTC - PREGNANCY OR BREAST FEEDING
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. OTC - ASK DOCTOR
    9. OVERDOSAGE
    10. OTC - PURPOSE
    11. PACKAGE LABEL AND PRINCIPAL DISPLAY:SMOKE FREE 21810598 100 TABLETS

Smoke Free Product Label

The following document was submitted to the FDA by the labeler of this product Schwabe North America, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - 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.


Otc - Pregnancy Or Breast Feeding



Pregnancy or Breast Feeding:

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


Otc - Keep Out Of Reach Of Children



Keep Out of Reach of Children:

Keep out of reach of children.


Otc - 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.


Otc - Purpose



Purpose:

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


Package Label And Principal Display:Smoke Free 21810598 100 Tablets



SmokeFree_21810598_04


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