EPI-MIST- racepinephrine hydrochloride aerosol, spray 
DRNATURALHEALING INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Prime Asthma Relief EpiMist

ACTIVE INGREDIENT

ACTIVE INGREDIENT: Racepinephrine HCL, USP (1% Epinephrine)

PURPOSE

BRONCHODILATOR

INDICATIONS AND USAGE

INDICATION USAGE JPEG

WARNING SECTION

INDICATION USAGE JPEG

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

EpiMist MAIN PANEL JPEGEpiMist MAIN PANEL JPEG

EPI-MIST 
racepinephrine hydrochloride aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15343-125
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RACEPINEPHRINE HYDROCHLORIDE (UNII: 336096P2WE) (RACEPINEPHRINE - UNII:GR0L9S3J0F) RACEPINEPHRINE.594 mg  in .120 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) .11808 mL  in .120 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 1.08 mg  in .120 mL
SODIUM CITRATE (UNII: 1Q73Q2JULR) .120 mg  in .120 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) .140 mg  in .120 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15343-125-221 in 1 KIT03/15/2018
115 mL in 1 INHALER; Type 1: Convenience Kit of Co-Package
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/FEIBusiness Operations
NEW LIFE RESOURCES169822900manufacture(15343-125)

Revised: 3/2018
Document Id: ada43ab1-6d9c-4707-b77b-905b81ef8705
Set id: cd4a46b6-e381-4b0b-b679-349f233f98e3
Version: 3
Effective Time: 20180320
 
DRNATURALHEALING INC