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  5. Label Information: Smoke Freee

FDA Label for Smoke Freee

View Indications, Usage & Precautions

Table of Contents

    1. DOSAGE & ADMINISTRATION
    2. WARNINGS
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. OTHER SAFETY INFORMATION
    5. OTC - PURPOSE
    6. OTC - ACTIVE INGREDIENT
    7. INACTIVE INGREDIENT
    8. INDICATIONS & USAGE
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Smoke Freee Product Label

The following document was submitted to the FDA by the labeler of this product New Sun 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.

Dosage & Administration



Directions: Before initial dose depress pump 4-5 times or until primed and spray 1 dose directly in mouth 4 to 6 times daily until symptoms improve.

Adult Dose: 3 Pump Sprays

Child's Dose (2-12): 2 Pump Sprays

Infants - 2 yrs: 1 Pump Spray


Warnings



Warnings: If symptoms persist or worsen, seek advice of a physician. If pregnant or breast-feeding, take only on advice of physician.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Other Safety Information



Other information: Tamper resistant for your protection. Use only if safety seal is intact.


Otc - Purpose



Indications: Temporarily relieves cravings for: • tobacco smoke • chew

Temporary relieves: • nervousness, anxiety & irritability when quitting • cough/shortness of breath • difficulty breathing • sensation of weight on chest from smoking


Otc - Active Ingredient



Active Ingredients: Arsenicum album, Caladium seguinum, Carbolicum acidum, Daphne indica, Eugenia jambosa, Kali phosphoricum, Lobelia inflata, Nicotinum, Nux vomica, Plantago major, Saccharum officinale, Staphysagria, Tabacum, Thuja occidentalis. ​Equal volumes of each ingredient in 10X, 30X, and 100X potencies.


Inactive Ingredient



Inactive Ingredient: Citric acid, potassium sorbate, purified water.


Indications & Usage



Indications: Temporarily relieves cravings for:

  • tobacco smoke 
  • chew

    • Temporary relieves:

    • nervousness, anxiety & irritability when quitting
    • cough/shortness of breath
    • difficulty breathing
    • sensation of weight on chest from smoking​

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