Naloxone Hydrochloride Spray, Metered
FDA Label NDC 0480-3478

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Teva Pharmaceuticals, Inc. for the product Naloxone Hydrochloride (NDC 0480-3478). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each spray), purpose, uses, directions, warning, other information, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each Spray)

→ Purpose

→ Uses

→ Directions

→ Warning

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Package/label Principal Display Panel – Carton Label

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 (Commercial Image 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 (Commercial Image 3)	Step 3: CALL CALL 911 immediately after giving the 1^st dose
Step 4 (Commercial Image 4)	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 (Commercial Image 5)	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.