Label: NALOXONE HYDROCHLORIDE spray, metered

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 29, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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

    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

    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

    Step 3: CALL

    • CALL 911immediately after giving the 1 stdose
    step 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

    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

  • 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 ®

    Relabeled by:

    Enovachem PHARMACEUTICALS

    Torrance, CA 90501

  • KEEP OUT OF REACH OF CHILDREN

  • Package/Label Principal Display Panel

    4 mg
  • INGREDIENTS AND APPEARANCE
    NALOXONE HYDROCHLORIDE 
    naloxone hydrochloride spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76420-867(NDC:0480-3478)
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N) NALOXONE HYDROCHLORIDE4 mg  in 0.1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76420-867-022 in 1 CARTON10/29/2024
    11 in 1 BLISTER PACK
    10.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20952209/23/2024
    Labeler - Asclemed USA, Inc. (059888437)
    Establishment
    NameAddressID/FEIBusiness Operations
    ASCLEMED USA INC. DBA ENOVACHEM059888437relabel(76420-867)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!