Label: NALOXONE HYDROCHLORIDE spray, metered

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 29, 2024

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  • 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)
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