FDA label 36f1f619-eff7-4e7b-a0d7-24c2a3db8a7e
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- SPL set ID
- 67130add-b80a-4a81-9750-1ebf2912da59
- SPL ID
- 36f1f619-eff7-4e7b-a0d7-24c2a3db8a7e
- Version
- 1
- Effective date
- 2011-04-25
- Source export date
- 2026-09-28
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:31:35
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 36f1f619-eff7-4e7b-a0d7-24c2a3db8a7e | id | |
| spl set id | 67130add-b80a-4a81-9750-1ebf2912da59 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Naloxone hydrochloride should be administered cautiously to persons including newborns of mothers who are known or suspected to be physically dependent on opioids. In such cases an abrupt and complete reversal of narcotic effects may precipitate an acute abstinence syndrome. The patient who has satisfactorily responded to naloxone should be kept under continued surveillance and repeated doses of naloxone should be administered, as necessary, since the duration of action of some narcotics may exceed that of naloxone. Naloxone is not effective against respiratory depression due to non-opioid drugs. Reversal of buprenorphineinduced respiratory depression may be incomplete. If an incomplete response occurs, respirations should be mechanically assisted.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Abrupt reversal of narcotic depression may result in nausea, vomiting, sweating, tachycardia, increased blood pressure, tremulousness, seizures and cardiac arrest. In postoperative patients, Iarger than necessary dosages of naloxone hydrochloride may result in significant reversal of analgesia, and in excitement. Hypotension, hypertension, ventricular tachycardia and fibrillation, and pulmonary edema have been associated with the use of naloxone postoperatively. (See "PRECAUTIONS" and "Usage in Adults, Postoperative Narcotic Depression.")
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.