FDA label 570fafbd-dc2b-d737-e063-6394a90a7322

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
8e928b79-2178-47ef-8427-6bb57f143261
SPL ID
570fafbd-dc2b-d737-e063-6394a90a7322
Version
6
Effective date
2026-07-20
Source export date
2026-09-28
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:08:23

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 exceed recommended dosage • If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. Do not use this product • for persistant or chronic cough, such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a Doctor • if you are now taking a prescription Monoamineoxidase 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 you are taking a prescription drug that contains an MAOI, ask a doctor or a pharmacist before taking this product. • if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a Doctor. Stop use and ask a Doctor • A persistent cough may be a sign of a serious condition; • If cough persists for more than one week, tend to recur, or is accompanied by fever, rash or persistent headache; • if symptoms do not improve within 7 days or are accompanied by fever.

Reported adverse events (FAERS/openFDA)#

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