FDA Label for Epi-mist
View Indications, Usage & Precautions
Epi-mist Product Label
The following document was submitted to the FDA by the labeler of this product Drnaturalhealing 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.
Active Ingredient
ACTIVE INGREDIENT: Racepinephrine HCL, USP (1% Epinephrine)
Purpose
BRONCHODILATOR
Indications And Usage
Warning Section
Dosage And Administration
DIRECTIONS
• Do not take more than directed
• Place your lips around the mouthpiece and squeeze the bulb while inhaling simultaneously to breathe in the epinephrine aerosol– see figure below for details
• Adults and children 4 years of age and over: Do not take more than one dose every 3 hours. Do not take more than 8 doses in a 24-hour period. The use of this product by children under the age of 12 should be supervised by an adult.
• For children’s usage between 4 to 12 years of age: an adult may squeeze the bulb while your child inhales.
• Please contact your doctor if your symptoms advance.
How Supplied
HOW SUPPLIED
Each unit of EpiMist contains 10 ml, 250 doses of epinephrine. Each dose (40 microliters) is delivered by one (1) turn-click of the device, containing 1% epinephrine solution made with racepinephrine hydrogen chloride, USP.
Storage And Handling
STORAGE AND HANDLING
1) Protect from light to reduce loss of the activity of the active ingredient.
2) Avoid excessive heat.
3) You can carry the whole set during daytime but avoid excessive heat and bright light.
4) When at home, it is recommended to store in refrigerator (35 to 40 oF).
5) After the liquid medicine is used out, dispose the plastic device properly.
Inactive Ingredient Section
INACTIVE INGREDIENT
Water, Edetate Disodium, Ascorbic Acid, Citric Acid, Polysobate-60. All USP grade.
Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away
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