FDA Label for Naloxone Hydrochloride
View Indications, Usage & Precautions
Naloxone Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Spray)
Naloxone hydrochloride 4 mg
Purpose
Emergency treatment of opioid overdose
Use(S)
- to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin
- this medicine can save a life
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.
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
- HOLD the nasal spray device with your thumb on the bottom of the plunger
- INSERT the nozzle into either NOSTRIL
- PRESS the plunger firmly to give the 1st dose
- 1 nasal spray device contains 1 dose
- CALL 911 immediately after giving the 1st dose
- WAIT 2 to 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 to 3 minutes until the person wakes up
- it is safe to keep giving doses
- 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
- For use in the nose only
- Do not test nasal spray device before use
- 1 nasal spray device contains 1 dose of medicine
- Each device sprays 1 time only
- 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
- HOLD the nasal spray device with your thumb on the bottom
of the plunger - INSERT the nozzle into either NOSTRIL
- PRESS the plunger firmly to give the 1st dose
- 1 nasal spray device contains 1 dose
- CALL 911 immediately after giving the 1st dose
- WAIT 2 to 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 to 3 minutes until the person
wakes up - it is safe to keep giving doses
- CONTINUE TO GIVE doses every 2 to 3 minutes until the person
- 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
Step 2: GIVE 1st dose in the nose
Step 3: CALL 911
Step 4: WATCH & GIVE
Step 5: STAY
Naloxone Hydrochloride Nasal Spray, 4 mg
Emergency Treatment of Opioid Overdose
Important:
Step 1: CHECK if you suspect an overdose:
Step 2: GIVE 1st dose in the nose
Step 3: CALL 911
Step 4: WATCH AND GIVE
Step 5: STAY
For opioid emergencies, call 911.For questions or more information about Naloxone Hydrochloride Nasal Spray, contact Amneal Pharmaceuticals at 1-877-835-5472.
Rev. 07-2023-04
Other Information
- store at room temperature or refrigerated, between 2°C to 25°C (36°F to 77°F)
- do not freeze
- avoid excessive heat above 40°C (104°F)
- protect from light
- this product is packaged in individually-sealed blisters. Do not use if the blister is open or torn, or if the device appears damaged.
Inactive Ingredients
benzalkonium chloride, disodium ethylenediaminetetraacetate, hydrochloric acid, purified water, and sodium chloride
Questions
1-877-835-5472 (Mon-Fri, 9AM-5PM EST)
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