FDA label d326094d-da65-4aa8-ba27-494f61b3ad37

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
72bb9fd7-c172-403e-84ad-5cdd9f7c6008
SPL ID
d326094d-da65-4aa8-ba27-494f61b3ad37
Version
2
Effective date
2019-05-28
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:23:49

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: 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 taking this product. • if you have a chronic pulmonary disease or shortness of breath unless directed by a doctor. Stop use and consult a doctor • if cough lasts more than 7 days, recurs or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. Ask a doctor before use if you have • persistent cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by too much phlegm (mucus) When using this product • do not exceed recommended dosage. • do not use for more than 7 days May cause or aggravate constipation. If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children. Overdose Warning In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Reported adverse events (FAERS/openFDA)#

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