FDA Label for Naloxone Hydrochloride

View Indications, Usage & Precautions

ACTIVE INGREDIENT (IN EACH SPRAY)
PURPOSE
USES
DIRECTIONS
WARNING
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS?
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – CARTON LABEL

Naloxone Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Teva Pharmaceuticals, 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

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 - commercial image 1	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 1^st dose in the nose 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 1^st dose 1 nasal spray device contains 1 dose
	Step 3: CALL CALL 911 immediately after giving the 1^st dose
	Step 4: WATCH & GIVE WAIT 2-3 minutes after the 1^st 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

Warning

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 below 77°F (25°C).
do not freeze
avoid excessive heat above 40°C (104°F)
protect from light
the 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, edetate disodium, sodium chloride buffered with sodium hydroxide/hydrochloric acid, water

Questions?

1-888-838-2872 between 9 am and 5 pm ET, Monday-Friday.
www.tevausa.com/our-products/tevagenerics

Package/Label Principal Display Panel – Carton Label

Original Prescription Strength
Easy to Use
Can Save a Life

Compare to the active
ingredient in NARCAN^®*

NDC 0480-3478-68

Naloxone Hydrochloride
Nasal Spray
4 mg

Emergency Treatment of
Opioid Overdose

Designed to Rapidly Reverse the
Effects of a Life-Threatening
Opioid Emergency

For use in nose only

2 Single-Dose Nasal Spray Devices
0.003 fl oz (0.1 mL) each

4 mg carton - commercial image 6

* Please review the disclaimer below.

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