CONFER: Comprehension of Over-the-Counter Naloxone for Emergency Response (Task 2 - Adolescents)

Data to Support Drug Product Communications as Used by the FDA

Attachment P Label Version N Injector Supine

CONFER: Comprehension of Over-the-Counter Naloxone for Emergency Response (Task 2 - Adolescents)

OMB: 0910-0695

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Drug Facts
Active ingredient (in each XX)

Purpose

Naloxone hydrochloride X mg...............................................Emergency treatment of opioid overdose

Uses



To “revive” someone during an overdose from many prescription pain medications or street
drugs such as heroin
This medicine can save a life

Directions
Step 1: CHECK:
 CHECK for a suspected overdose: the person will not wake
up or is very sleepy or not breathing well
 yell “Wake up!”
 shake the person gently
 if the person is not awake, go to Step 2

Step 2: GIVE 1st dose
 GIVE the 1st dose of this medicine
 place the injector on the LEG above the knee and press
down

Step 3: CALL


CALL 911 immediately after giving the 1st dose

Step 4: WATCH & GIVE
 WAIT 2-3 minutes after the 1st dose to give the medicine
time to work


if the person wakes up: Go to Step 5



if the person does not wake up:


CONTINUE TO GIVE doses every 2-3 minutes until
the person wakes up



it is safe to keep giving doses

Step 5: STAY
 STAY until ambulance arrives: even if the person wakes up

 GIVE another dose if the person becomes very sleepy again
 You may need to give all the doses in the pack

Warnings
When using this product some people may experience symptoms when they wake up, such
as shaking, sweating, nausea, or feeling angry. This is to be expected.

Other information• store at room temperature • [advise insert tamper evident statement here]
Inactive Ingredients
Questions?
(phone number, website)

LABEL N-Injector 6.22.17


File Typeapplication/pdf
AuthorCarrie Salsman
File Modified2017-08-04
File Created2017-06-22

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