FDA label 927c86b9-9f54-42ae-89c1-0e44a2a5df89
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
- 03af48c8-58c9-4ce0-9b8b-d5481ba7da95
- SPL ID
- 927c86b9-9f54-42ae-89c1-0e44a2a5df89
- Version
- 1
- Effective date
- 2012-03-20
- Source export date
- 2026-10-12
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:06:03
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 | 927c86b9-9f54-42ae-89c1-0e44a2a5df89 | id | |
| spl set id | 03af48c8-58c9-4ce0-9b8b-d5481ba7da95 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS May be habit forming. Hydrocodone can produce drug dependence of the morphine type and therefore, has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon requested administration of this product and it should be used with the same degree of caution appropriate to the use of other narcotic drugs (see Drug, Abuse and Dependence section).
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Adverse reactions include drowsiness, lassitude, nausea, giddiness, constipation, respiratory depression, addiction, blurred vision, cardiac palpitations, flushing, increased irritability or excitement. The most frequently observed adverse reactions include lightheadedness, dizziness, drowsiness, sedation, nausea and vomiting. These effects seem to be more predominate in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Respiratory System: Hydrocodone produces close-related respiratory depression by acting directly on the brain stem respiratory centers. Cardivascular: Hypertension, postural hypotension and palpitations. Genitourinary System: Ureleral spasm, spasm of vesicle sphincters and urinary retention have been reported with opiates. Central Nervous System : Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes and blurred vision. Gastrointestinal System: Nausea and vomiting occur more frequently in ambulatory patients than in recumbent patients.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.