FDA label 92480fe8-e378-4202-8364-bed74911529c

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: cfae8153-3cf8-4cb2-b71d-2062b1db1e37
SPL ID: 92480fe8-e378-4202-8364-bed74911529c
Version: 1
Effective date: 2011-02-01
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:22:27

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		92480fe8-e378-4202-8364-bed74911529c	id
spl set id		cfae8153-3cf8-4cb2-b71d-2062b1db1e37	set_id

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Hydrocodone can produce drug dependence and therefore has the potential for being abused. This product should be prescribed and administered with the appropriate degree of caution. Considerable caution should be exercised in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure and prostatic hypertrophy. The elderly (60 years and older) are more likely to exhibit adverse reactions. Antihistamines may cause excitability, especially in children. At dosages higher that the recommended dose, nervousness, dizziness or sleeplessness may occur.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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

adverse reactions

6 ADVERSE REACTIONS Adverse reactions include drowsiness, lassitude, nausea, giddiness, constipation, respiratory depression, addiction, dryness of mouth, blurred vision, cardiac palpitations, flushing, increased irritability or excitement (especially in children).

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.