Naloxone Pilot Label Comprehension Questionnaire to Optimize the Drug Facts Label (Task 2)

Data to Support Drug Product Communications as Used by the FDA

Attachment P Label Version M Nasal Supine

Naloxone Pilot Label Comprehension Questionnaire to Optimize the Drug Facts Label (Task 2)

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 (these drugs are called “opioids”)

this medicine can save a life

Directions
Step 1: CHECK if you suspect an overdose:


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
 insert in NOSE and press

Step 3: CALL
 CALL 911 immediately after giving the 1st dose

Step 4: WATCH & GIVE
 WAIT 2-3 minutes after the 1st dose
 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.

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

LABEL M Revised-Nasal 3.5.17


File Typeapplication/pdf
File TitleMicrosoft Word - Label Version M Revised 3.5.17_Nasal Supine_clean
Authormbeck
File Modified2017-04-19
File Created2017-03-15

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