FDA label 9870dbfc-91f0-4a22-a740-fcc42824ab56
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
- f9e3d9fc-59fe-453c-a799-6f4d3eacaf36
- SPL ID
- 9870dbfc-91f0-4a22-a740-fcc42824ab56
- Version
- 3
- Effective date
- 2011-02-07
- Source export date
- 2026-10-12
- Source partition
- 1
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:26:24
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 | 9870dbfc-91f0-4a22-a740-fcc42824ab56 | id | |
| spl set id | f9e3d9fc-59fe-453c-a799-6f4d3eacaf36 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS KEEP RESUSCITATIVE AND ENDOTRACHEAL INTUBATION EQUIPMENT AND OXYGEN READILY AVAILABLE. MAINTAIN PATENCY OF THE AIRWAY AT ALL TIMES. This drug should be administered only by persons qualified in the use of intravenous anesthetics. Avoid extravasation or intra-arterial injection.
warnings
WARNINGS Intravenous administration of Sterile Water for Injection, USP without a solute may result in hemolysis. Use aseptic technique for preparing Pentothal solutions during withdrawal from reconstituted single -use containers. Administer only clear reconstituted solutions. Use within 24 hours after reconstitution. Discard unused portions.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Adverse reactions include respiratory depression, myocardial depression, cardiac arrhythmias, prolonged somnolence and recovery, sneezing, coughing, bronchospasm, laryngospasm and shivering. Anaphylactic and anaphylactoid reactions to Pentothal (Thiopental Sodium for Injection) have been reported. Symptoms, e.g., urticaria, bronchospasm, vasodilation and edema should be managed by conventional means. Rarely, immune hemolytic anemia with renal failure and radial nerve palsy have been reported.
adverse reactions
ADVERSE REACTIONS Reactions which may occur because of the diluent, technique of preparation or mixing, or administration of reconstituted solutions of Pentothal include febrile response or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the injection, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of unused solution (or the used container or syringe) for examination if deemed necessary.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.