boxed warning
Caution: do not use if imprinted seal under cap is broken or missing.
FDA label 45d2f472-0372-f59c-e063-6394a90ab537
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
- e217672e-ba0a-e79e-e053-2a95a90a6cd1
- SPL ID
- 45d2f472-0372-f59c-e063-6394a90ab537
- Version
- 5
- Effective date
- 2025-12-13
- Source export date
- 2026-10-12
- 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/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:58:04
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 | 45d2f472-0372-f59c-e063-6394a90ab537 | id | |
| spl set id | e217672e-ba0a-e79e-e053-2a95a90a6cd1 | set_id |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Warnings Ask doctor before use if you have persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema cough accompanied by excessive phlegm (mucus) Stop use and ask a doctor if Symptoms are accompanied by fever, rash or persistent headache cough persists for more than 1 week or tends to recur A persistent cough may be a sign of a serious condition If pregnant or breast-feeding , ask a health professional before use.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.