Label: NALOXONE HYDROCHLORIDE spray
- NDC Code(s): 46122-812-71
- Packager: AMERISOURCE BERGEN
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 10, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each spray)
- Purpose
- Uses
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Directions
Emergency Treatment of Opioid Overdose
Important:
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- For use in the nose only
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- Do not test nasal spray device before use
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- 1 nasal spray device contains 1 dose of medicine
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- 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
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.
- Warning
- Other information
- Inactive Ingredients
- Questions?
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Package/Label Principal Display Panel
Good Neighbor Pharmacy
NDC 46122-812-71
Original Prescription Strength
Naloxone HCl Nasal Spray 4 mg
Emergency Treatment of Opioid Overdose
Designed to Rapidly Reverse the Effects of a Life-Threatening Opioid Emergency
Easy to Use
Can Save a Life
For use in nose only
2 SINGLE-DOSE NASAL SPRAY DEVICES
0.003 FL OZ (0.1mL) EACH
Safe to Use Even if Opioids are Not Present
*Good Neighbor Pharmacy® Naloxone HCl Nasal Spray 4 mg is not manufactured or distributed by Emergent Operations Ireland Limited.
Distributed By AmerisourceBergen
1 West First Avenue,
Conshohocken, PA 19428
Questions or Concerns?
www.mygnp.com
Manufactured by Padagis®
Yeruham, Israel
Product of France
64QJ8 GP C1
64Q00 RT QS2
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INGREDIENTS AND APPEARANCE
NALOXONE HYDROCHLORIDE
naloxone hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-812 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N) NALOXONE HYDROCHLORIDE 4 mg in 0.1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM CHLORIDE (UNII: 451W47IQ8X) HYDROCHLORIC ACID (UNII: QTT17582CB) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46122-812-71 2 in 1 CARTON 03/12/2025 1 0.1 mL in 1 VIAL, SINGLE-DOSE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211951 03/12/2025 Labeler - AMERISOURCE BERGEN (007914906)