Naloxone Hydrochloride NALOXONE HYDROCHLORIDE ACTAVIS PHARMA, INC. FDA Approved Uses to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin this medicine can save a life
FunFoxMeds box
Route
NASAL
Applications
ANDA209522

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each spray) Naloxone hydrochloride 4 mg
Inactive Ingredients
Inactive ingredients benzalkonium chloride edetate disodium sodium chloride buffered with sodium hydroxide/hydrochloric acid water
Strengths
4 mg
Quantities
1 ml
Treats Conditions
Uses To Revive Someone During An Overdose From Many Prescription Pain Medications Or Street Drugs Such As Heroin This Medicine Can Save A Life

Identifiers & Packaging

Container Type BOX
UNII
F850569PQR
Packaging

PACKAGE LABEL PRINCIPAL DISPLAY PANEL NOT FOR RESALE FOR NON-RETAIL DISTRIBUTION Compare to the active ingredient in NARCAN ®* NDC 0591-3871-99 Naloxone Hydrochloride Nasal Spray 4mg Emergency Treatment of Opioid Overdose Designed to Rapidly Reverse the Effects of a Life-Threatening Opioid Emergency For use in nose only 2 Single-Dose Nasal Spray Devices 0.003 fl oz (0.1 mL) each 4 mg carton

Package Descriptions
  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL NOT FOR RESALE FOR NON-RETAIL DISTRIBUTION Compare to the active ingredient in NARCAN ®* NDC 0591-3871-99 Naloxone Hydrochloride Nasal Spray 4mg Emergency Treatment of Opioid Overdose Designed to Rapidly Reverse the Effects of a Life-Threatening Opioid Emergency For use in nose only 2 Single-Dose Nasal Spray Devices 0.003 fl oz (0.1 mL) each 4 mg carton

Overview

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

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

Dosage & Administration

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 st 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 1 st dose 1 nasal spray device contains 1 dose Step 3: CALL CALL 911 immediately after giving the 1 st dose Step 4: WATCH & GIVE WAIT 2-3 minutes after the 1 st 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 step 1 step 2 step 3 step 4 step 5

Warnings & Precautions
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.
Purpose

Purpose Emergency treatment of opioid overdose

Keep Out of Reach of Children

*This product is not affiliated with, manufactured by, or produced by the makers or owners of NARCAN ® Manufactured For: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 Rev. A 1/2024

Questions

Questions? 1-888-838-2872 between 9 am and 5 pm ET, Monday-Friday. www.tevausa.com/our-products/tevagenerics


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