FDA label ef97de17-13df-40af-bbb9-77135df01e44
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
- ef97de17-13df-40af-bbb9-77135df01e44
- SPL ID
- ef97de17-13df-40af-bbb9-77135df01e44
- Version
- 1
- Effective date
- 2010-12-28
- Source export date
- 2026-09-28
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:58:52
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 | ef97de17-13df-40af-bbb9-77135df01e44 | id | |
| spl set id | ef97de17-13df-40af-bbb9-77135df01e44 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS WARNINGSRespiratory Depression:At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brainstem respiratory center. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodicbreathing.Head Injury and Increased Intracranial Pressure:The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggeratedin the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, narcoticsproduce
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS adverse reactions which may obscure the clinical course of patients with head injuries.Acute Abdominal Conditions:The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.