EPINEPHRINE PROFESSIONAL EMS- epinephrine convenience kit kit

Epinephrine Professional EMS by

Drug Labeling and Warnings

Epinephrine Professional EMS by is a Prescription medication manufactured, distributed, or labeled by Focus Health Group, Par Sterile Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Dosage and Administration:

Always follow the prescriber’s order for dosing and administration.

Adrenamine may be administered for anaphylaxis:

o Adults and Children 30 kg (66 lbs) or more: 0.3 to 0.5 mg (0.3 to 0.5 mL) intramuscularly or subcutaneously into anterolateral aspect of the thigh every 5 to 10 minutes as necessary

o Children 30 kg (66 lbs) or less: 0.01 mg/kg (0.01 mL/kg), up to 0.3 mg (0.3 mL), intramuscularly or subcutaneously into anterolateral aspect of the thigh every 5 to 10 minutes as necessary

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EPINEPHRINE PROFESSIONAL EMS 
epinephrine convenience kit kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 24357-012

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24357-012-12	1 in 1 CARTON; Type 0: Not a Combination Product	07/01/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 VIAL	1 mL
Part 2	4 PACKET	4 mL

Part 1 of 2

ADRENALIN 
epinephrine injection

Product Information
Item Code (Source)	NDC: 42023-159
Route of Administration	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM METABISULFITE (UNII: 4VON5FNS3C)	0.457 mg  in 1 mL
TARTARIC ACID (UNII: W4888I119H)	2.25 mg  in 1 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)	1 mg  in 1 mL
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)	7.3 mg  in 1 mL
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)	0.2 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42023-159-01	1 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA204200	07/01/2013

Part 2 of 2

MCKESSON ALCOHOL PREP PAD 
isopropyl alcohol swab

Product Information
Item Code (Source)	NDC: 68599-5804
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68599-5804-1	1 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/09/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA204200	07/01/2019

Labeler - Focus Health Group (826939949)

Registrant - Focus Health Group (826939949)

Establishment
Name	Address	ID/FEI	Business Operations
Par Sterile Products LLC		808402890	manufacture(42023-159)

Establishment
Name	Address	ID/FEI	Business Operations
Focus Health Group		826939949	manufacture(24357-012)