DOSAGE & ADMINISTRATION SECTION.
Directions. Step 1: CHECK if you suspect an overdoseCHECK for suspected overdose: the person will not wake up or is very sleepy or not breathing wellyell Wake upshake the person gentlyif the person is not awake, go to Step Step 2: GIVE 1st dose in the noseHOLD the nasal spray device with your thumb on the bottom of the plungerINSERT the nozzle into either NOSTRILPRESS the plunger firmly to give the 1st dose1 nasal spray device contains dose Step 3: CALL 911CALL 911 immediately after giving the 1st dose Step 4: WATCH GIVEWAIT to minutes after the 1st dose to give the medicine time to workif the person wakes up: Go to Step 5if the person does not wake up:CONTINUE TO GIVE doses every to minutes until the person wakes upit is safe to keep giving doses Step 5: STAYSTAY until ambulance arrives: even if the person wakes upGIVE another dose if the person becomes very sleepy againYou may need to give all the doses in the pack. CHECK for 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. 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. nasal spray device contains dose. CALL 911 immediately after giving the 1st dose. WAIT to 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 to minutes until the person wakes up. it is safe to keep giving doses. 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. 1. 2. 3. 4. 5.
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INACTIVE INGREDIENT SECTION.
Inactive ingredients. benzalkonium chloride, disodium ethylenediaminetetraacetate, hydrochloric acid, purified water, and sodium chloride.
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INDICATIONS & USAGE SECTION.
Use(s). to revive someone during an overdose from many prescription pain medications or street drugs such as herointhis medicine can save life. to revive someone during an overdose from many prescription pain medications or street drugs such as heroin. this medicine can save life.
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OTC - ACTIVE INGREDIENT SECTION.
Active ingredient (in each spray). Naloxone hydrochloride mg.
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OTC - PURPOSE SECTION.
Purpose. Emergency treatment of opioid overdose.
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OTC - QUESTIONS SECTION.
Questions or comments. 1-877-835-5472 (Mon-Fri, 9AM-5PM EST).
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OTC - WHEN USING 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.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Principal Display Panel. ifc.
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SPL PATIENT PACKAGE INSERT SECTION.
DIRECTIONS. Naloxone Hydrochloride Nasal Spray, mgEmergency Treatment of Opioid OverdoseImportant:For use in the nose onlyDo not test nasal spray device before use1 nasal spray device contains dose of medicineEach device sprays time onlyStep 1: CHECK if you suspect an overdose:CHECK for suspected overdose: the person will not wake up or is very sleepy or not breathing wellyell Wake upshake the person gentlyif the person is not awake, go to Step 2Step 2: GIVE 1st dose in the noseHOLD the nasal spray device with your thumb on the bottom of the plungerINSERT the nozzle into either NOSTRILPRESS the plunger firmly to give the 1st dose1 nasal spray device contains doseStep 3: CALL 911CALL 911 immediately after giving the 1st doseStep 4: WATCH AND GIVEWAIT to minutes after the 1st dose to give the medicine time to workif the person wakes up: Go to Step 5if the person does not wake up: CONTINUE TO GIVE doses every to minutes until the person wakes upit is safe to keep giving doses Step 5: STAYSTAY until ambulance arrives: even if the person wakes upGIVE another dose if the person becomes very sleepy againYou may need to give all the doses in the packFor opioid emergencies, call 911.For questions or more information about Naloxone Hydrochloride Nasal Spray, contact Amneal Pharmaceuticals at 1-877-835-5472.Rev. 07-2023-04. For use in the nose only. Do not test nasal spray device before use. nasal spray device contains dose of medicine. Each device sprays time only. CHECK for 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. 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. nasal spray device contains dose. CALL 911 immediately after giving the 1st dose. WAIT to 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 to minutes until the person wakes upit is safe to keep giving doses CONTINUE TO GIVE doses every to minutes until the person wakes up. it is safe to keep giving doses. 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. hand drawing. step 1. step 2. step 3. step 4. step 5.
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SPL UNCLASSIFIED SECTION.
Other information. store at room temperature or refrigerated, between 2C to 25C (36F to 77F)do not freezeavoid excessive heat above 40C (104F)protect from lightthis product is packaged in individually-sealed blisters. Do not use if the blister is open or torn, or if the device appears damaged.. store at room temperature or refrigerated, between 2C to 25C (36F to 77F). do not freeze. avoid excessive heat above 40C (104F). protect from light. this product is packaged in individually-sealed blisters. Do not use if the blister is open or torn, or if the device appears damaged.
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WARNINGS SECTION.
Warnings. 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.
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