NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE is an FDA drug label for the active ingredient NALOXONE HYDROCHLORIDE manufactured by A-S Medication Solutions administered by NASAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231227.
- Generic name
- NALOXONE HYDROCHLORIDE
- Manufacturer
- A-S Medication Solutions
- Product type
- HUMAN OTC DRUG
- Route
- NASAL
- Dosage form
- N/A
- NDC
- 50090-6963
- Application
- ANDA211951
- Label effective
- 20231227
Active ingredients
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 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 Step 1 Step 2 Step 3 Step 4 Step 5
Contraindications
Not available.
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.
Adverse Reactions
Not available.