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
Description

Naloxone hydrochloride 4 mg

Purpose

Emergency treatment of opioid overdose

Medication Information

Purpose

Emergency treatment of opioid overdose

Description

Naloxone hydrochloride 4 mg

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

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

www.tevausa.com/our-products/tevagenerics

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

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
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

Purpose

Emergency treatment of opioid overdose

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.
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
Questions?

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

www.tevausa.com/our-products/tevagenerics

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

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