FDA label b1558ece-ba75-465e-9d3f-75840ce98cb4
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
- c51e9180-72cd-43e6-ae49-4358f39cb88a
- SPL ID
- b1558ece-ba75-465e-9d3f-75840ce98cb4
- Version
- 1
- Effective date
- 2012-02-24
- Source export date
- 2026-09-28
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:31:09
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 | b1558ece-ba75-465e-9d3f-75840ce98cb4 | id | |
| spl set id | c51e9180-72cd-43e6-ae49-4358f39cb88a | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Before prescribing medication to suppress or modify a cough, it is important that the underlying cause of the cough is identified, that modification of the cough does not increase the risk of clinical or physiological complications, and that appropriate therapy for the primary disease is instituted.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
6 ADVERSE REACTIONS Signs of potential side effects that require medical attention only if persistant include, but are not limited to: mild dizziness, mild drowsiness, nausea or vomiting, stomach pain. Those indicating immediate medical attention include confusion, drowsiness or dizziness (severe), nausea or vomiting (severe), unusual excitement, nervousness, restlessness, or irritability (severe).
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.