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 (canonical bytes are SHA-256 checked before publication)

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

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

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#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

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.