warnings
WARNINGS Addiction can result from opium usage. Opium preparations should be given in the smallest effective dose and as infrequently as possible to minimize the development of tolerance and physical dependence.
FDA label 4d7a3523-8729-4340-bd3d-ba20222d137f
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
- 3ad95865-a77c-41da-b572-e5c0bb404c79
- SPL ID
- 4d7a3523-8729-4340-bd3d-ba20222d137f
- Version
- 2
- Effective date
- 2021-05-07
- Source export date
- 2026-10-12
- Source partition
- 10
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:35:46
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 | 4d7a3523-8729-4340-bd3d-ba20222d137f | id | |
| spl set id | 3ad95865-a77c-41da-b572-e5c0bb404c79 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Constipation, nausea, and vomiting may occur in some patients. Pruritus and urticaria have been observed.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.