FDA label ba9ffd36-c22d-47c5-ab0a-954791e8ddd5

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
e2288500-5d12-4e5e-ba46-46e21eadfd94
SPL ID
ba9ffd36-c22d-47c5-ab0a-954791e8ddd5
Version
6
Effective date
2013-01-21
Source export date
2026-10-12
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:34:31

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 more than the recommended dosage. If drowsiness occurs, do not drive or operate machinery. 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacists before taking this product. Ask a doctor before use is you have a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema. difficulty in urination due to enlargement of the prostate gland. Glaucoma. Thyroid disease. a chough that occurs with too much phlegm (mucus). Stop use a nd ask a doctor if Cough lasts more than seven days, returns or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding , Do Not Use. Keep out of reach of children. In case of accidental overdose get medical help or contact a poison control center right away.

Reported adverse events (FAERS/openFDA)#

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