Naloxone Hydrochloride Spray, Metered
FDA Label NDC 76420-867

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Asclemed Usa, Inc. for the product Naloxone Hydrochloride (NDC 76420-867). 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

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 medicationsor 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: CHECKfor 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 ^stdose in the nose HOLDthe nasal spray device with your thumb on the bottom of the plunger INSERTthe nozzle into either NOSTRIL PRESSthe plunger firmly to give the 1 ^stdose 1 nasal spray device contains 1 dose
Step 3 (Commercial Image 3)	Step 3: CALL CALL 911immediately after giving the 1 ^stdose
Step 4 (Commercial Image 4)	Step 4: WATCH & GIVE WAIT2-3 minutes after the 1 ^stdose 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 GIVEdoses every 2-3 minutes until the person wakes up it is safe to keep giving doses
Step 5 (Commercial Image 5)	Step 5: STAY STAYuntil ambulance arrives: even if the person wakes up GIVEanother dose if the person becomes very sleepy again You may need to give all the doses in the pack

Warning

When using this productsome 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

4 mg (Commercial Image 6)

* Please review the disclaimer below.

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