EPI-MIST- racepinephrine hydrochloride aerosol, spray

Epi-Mist by

Drug Labeling and Warnings

Epi-Mist by is a Otc medication manufactured, distributed, or labeled by DRNATURALHEALING INC, NEW LIFE RESOURCES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

EPI-MIST 
racepinephrine hydrochloride aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15343-125
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RACEPINEPHRINE HYDROCHLORIDE (UNII: 336096P2WE) (RACEPINEPHRINE - UNII:GR0L9S3J0F)	RACEPINEPHRINE	.594 mg  in .120 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15343-125-22	1 in 1 KIT	03/15/2018
1		15 mL in 1 INHALER; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/15/2015

Labeler - DRNATURALHEALING INC (129613308)

Registrant - DRNATURALHEALING INC (129613308)

Establishment
Name	Address	ID/FEI	Business Operations
NEW LIFE RESOURCES		169822900	manufacture(15343-125)