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Epi-Mist

Medically reviewed by Drugs.com. Last updated on Mar 10, 2021.

Dosage form: aerosol, spray
Ingredients: RACEPINEPHRINE HYDROCHLORIDE .594mg in .120mL
Labeler: DRNATURALHEALING INC
NDC Code: 15343-125

Prime Asthma Relief EpiMist

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

DISPLAY PANEL

EPI-MIST 
racepinephrine hydrochloride aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15343-125
Route of AdministrationRESPIRATORY (INHALATION)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RACEPINEPHRINE HYDROCHLORIDE (RACEPINEPHRINE) RACEPINEPHRINE.594 mg  in .120 mL
Inactive Ingredients
Ingredient NameStrength
WATER.11808 mL  in .120 mL
SODIUM CHLORIDE1.08 mg  in .120 mL
SODIUM CITRATE.120 mg  in .120 mL
CITRIC ACID MONOHYDRATE.140 mg  in .120 mL
Packaging
#Item CodePackage Description
1NDC:15343-125-221 INHALER in 1 KIT
115 mL in 1 INHALER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/15/2015
Labeler - DRNATURALHEALING INC (129613308)
Registrant - DRNATURALHEALING INC (129613308)
Establishment
NameAddressID/FEIOperations
NEW LIFE RESOURCES169822900manufacture(15343-125)

 
DRNATURALHEALING INC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.