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NALOXONE HCL NASAL SPRAY 4MG 2 X 0.1ML - 4 mg/.1mL - SPRAY
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NALOXONE HCL NASAL SPRAY 4MG 2 X 0.1ML

Generic: naloxone hydrochloride

NALOXONE HCL NASAL SPRAY 4MG 2 X 0.1ML

NDC:46122-0812-71
Manufacturer:AMERISOURCE BERGEN
Strength:4 mg/.1mL
Dosage Form:SPRAY
Route:NASAL

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Drug Information

Identification

Generic Name

naloxone hydrochloride

Brand Name

NALOXONE HYDROCHLORIDE

Labeler / Distributor

AMERISOURCE BERGEN

Product Type

HUMAN OTC DRUG

Administration

Dosage Form

SPRAY

Route of Administration

NASAL

FDA Application Number

ANDA211951

Active Ingredients

IngredientStrength
NALOXONE HYDROCHLORIDE4 mg/.1mL

Pharmacological Class

Opioid AntagonistOpioid Antagonists [MoA]

Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.

Clinical Drug Information

Indications & Usage

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

Warnings

Warning 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.

Dosage & Administration

Directions Emergency Treatment of Opioid Overdose Important: • For use in the nose only • Do not test nasal spray device before use • 1 nasal spray device contains 1 dose of medicine • Each device sprays 1 time only Do not test nasal spray device before use 1 nasal spray device contains 1 dose of medicine Each device sprays 1 time only 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 1st dose 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 1st dose • 1 nasal spray device contains 1 dose Step 3: CALL • CALL 911 immediately after giving the 1st dose Step 4: WATCH & GIVE • WAIT 2-3 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 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 For opioid emergencies, call 911 . For questions on Naloxone HCl Nasal Spray 4 mg, call Padagis ® at 1-866-634-9120 or go to www.padagis.com. Step 1 Step 2 holding nasal spray device Step 3 Step 4 Step 5

Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.