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 (canonical bytes are SHA-256 checked before publication)

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

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

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#

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

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.