Adrenalin (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

Adrenalin 30 mg/30 mL (1 mg/mL) Multiple Dose Vials:

Each carton contains 1 multiple dose vial containing 30 mg/30 mL (1 mg/mL) Adrenalin (epinephrine injection, USP) solution in a 36 mL amber glass vial.

NDC 42023-168-89 30 mL Multiple Dose Vial

Vial and contents must be discarded 30 days after initial use.

Store between 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Epinephrine is light sensitive. Protect from light and freezing.

Inspect visually for particulate matter and discoloration prior to administration. Do not use the solution if it is colored or cloudy, or if it contains particulate matter.

17 PATIENT COUNSELING INFORMATION

Advise patients or their caregivers about common adverse reactions associated with the use of epinephrine including an increase in heart rate, the sensation of a more forceful heartbeat, palpitations, sweating, nausea and vomiting, difficulty breathing, pallor, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These symptoms and signs usually subside rapidly, especially with rest, quiet and recumbent positioning.

Warn patients with a good response to initial treatment about the possibility of recurrence of symptoms and instruct patients to obtain proper medical attention if symptoms return.

Warn patients with diabetes that they may develop increased blood glucose levels following epinephrine administration.

Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site [see Warnings and Precautions (5.2)].

Adrenalin is a registered trademark of Par Pharmaceutical, Inc.

Registered Trademark No. 53,934

Distributed by:

Par Pharmaceutical

Chestnut Ridge, NY 10977

PREMIER ProRx®

PREMIERProRx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license.

I08/2020

OS168P-01-95-01

3003885

PRINCIPLE DISPLAY PANEL — 30ML VIAL LABEL

PRINCIPAL DISPLAY PANEL — 30 mL Vial Label

NDC 42023-168-89

Rx Only

Adrenalin®

(epinephrine

30 mg/30 mL

(1 mg/mL)

For Intravenous Infusion, Intramuscular and S ubcutaneous Use

NOT for Ophthalmic Use

30 mL Multiple Dose Vial

Vial Label
(click image for full-size original)

Image 2

ADRENALIN epinephrine injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42023-168
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPINEPHRINE (EPINEPHRINE) EPINEPHRINE 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 6.15 mg in 1 mL
SODIUM METABISULFITE 0.457 mg in 1 mL
SODIUM HYDROXIDE 0.920 mg in 1 mL
TARTARIC ACID 2.25 mg in 1 mL
EDETATE DISODIUM 0.20 mg in 1 mL
CHLOROBUTANOL 5.25 mg in 1 mL
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42023-168-89 1 VIAL in 1 CARTON contains a VIAL
1 30 mL in 1 VIAL This package is contained within the CARTON (42023-168-89)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204640 12/04/2020
Labeler — Par Pharmaceutical, Inc. (092733690)
Registrant — Par Pharmaceutical Inc. (092733690)

Revised: 08/2020 Par Pharmaceutical, Inc.

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