boxed warning
Caution: do not use if imprinted seal under cap is broken or missing
FDA label 45d314c2-0246-188b-e063-6394a90a5b9a
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
- e22b0c01-390f-2743-e053-2995a90aee29
- SPL ID
- 45d314c2-0246-188b-e063-6394a90a5b9a
- Version
- 4
- Effective date
- 2025-12-13
- Source export date
- 2026-09-28
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:54:44
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 | 45d314c2-0246-188b-e063-6394a90a5b9a | id | |
| spl set id | e22b0c01-390f-2743-e053-2995a90aee29 | 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 Do not use if you are now taking a prescription Monoamine Oxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before using this product. Ask a doctor before use if you have Persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis or emphysema Cough accompanied by excessive phegm (mucus) Stop use and ask a doctor if Symptons 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 healthcare professional before use.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.