Naloxone Hydrochloride

Label at a glance#

Contacts and useful links#

PhoneLabel contact1-888-838-2872

Websitewww.tevausa.comwww.tevausa.com/our-products/tevagenerics

Label contents#

Full prescribing information#

Active ingredient (in each spray)

OTC - ACTIVE INGREDIENT SECTION

Naloxone hydrochloride 4 mg

Purpose

OTC - PURPOSE SECTION

Emergency treatment of opioid overdose

Uses

INDICATIONS & USAGE SECTION

• to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin
• this medicine can save a life

Directions

DOSAGE & ADMINISTRATION SECTION

step 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	Step 2: GIVE 1st 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 1st dose 1 nasal spray device contains 1 dose
step 3	Step 3: CALL CALL 911 immediately after giving the 1st dose
step 4	Step 4: WATCH & GIVE WAIT 2-3 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 2-3 minutes until the person wakes up it is safe to keep giving doses
step 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

WARNINGS SECTION

• 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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

benzalkonium chloride, edetate disodium, sodium chloride buffered with sodium hydroxide/hydrochloric acid, water

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Safe to Use Even if Opioids are Not Present

*This product is not affiliated with, manufactured by, or produced by
the makers or owners of NARCAN^®

Manufactured For: Teva Pharmaceuticals USA, Inc.
Parsippany, NJ 07054

Rev. A 1/2024

Package/Label Principal Display Panel – Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

DailyMed Billing Units#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

• Naloxone Hydrochloride
• NALOXONE
• BENZALKONIUM CHLORIDE
• EDETATE DISODIUM
• SODIUM CHLORIDE
• HYDROCHLORIC ACID
• WATER

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Observed Orange Book normalized TE history#

Observed Orange Book exclusivity history#

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.