drug facts

drug facts
SPL v1
SPL
SPL Set ID 7acf3bde-f858-4fbc-8a11-6741a3d27b8e
Route
nasal
Published
Effective Date 2024-10-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
naloxone (4 mg)
Inactive Ingredients
benzalkonium chloride edetate disodium sodium chloride hydrochloric acid water

Identifiers & Packaging

Marketing Status
anda active Since 2024-09-23
Purpose

Emergency treatment of opioid overdose

Description

Naloxone hydrochloride 4 mg

Medication Information

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

Emergency treatment of opioid overdose

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

Step 2: GIVE 1 stdose 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 stdose
  • 1 nasal spray device contains 1 dose

Step 3: CALL

  • CALL 911 immediately after giving the 1 stdose

Step 4: WATCH & GIVE

  • WAIT 2-3 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 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
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

Description

Naloxone hydrochloride 4 mg

Questions?

1-888-838-2872 between 9 am and 5 pm ET, Monday-Friday.

www.tevausa.com/our-products/tevagenerics

Section 42229-5
 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 ®

Relabeled by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

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.
Active Ingredient (in Each Spray)

Naloxone hydrochloride 4 mg

Package/label Principal Display Panel

Structured Label Content

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

Emergency treatment of opioid overdose

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

Step 2: GIVE 1 stdose 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 stdose
  • 1 nasal spray device contains 1 dose

Step 3: CALL

  • CALL 911 immediately after giving the 1 stdose

Step 4: WATCH & GIVE

  • WAIT 2-3 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 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
Other Information (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

Section 42229-5 (42229-5)
 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 ®

Relabeled by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

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.
Active Ingredient (in Each Spray) (Active ingredient (in each spray))

Naloxone hydrochloride 4 mg

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:07.270314 · Updated: 2026-03-14T23:04:37.184149