FDA label 8a5bd0ab-7665-478a-a5a9-26a114c95724

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
794f410f-d34d-43de-a5fc-55a913af8ac5
SPL ID
8a5bd0ab-7665-478a-a5a9-26a114c95724
Version
4
Effective date
2021-10-15
Source export date
2026-10-12
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:48:47

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 a persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a doctor. Ask a doctor before use if a child has a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or empgysema, or where cough is accompanied by excessive phlegm (mucus), unless directed by a doctor heart disease high blood pressure thyroid disease diabetes Stop use and ask a doctor if nervousness, dizziness or sleeplessness occur if symptoms do not improve within 7 days or are accompanied by fever Ask a doctor before use if a child is taking sedatives or tranquilizers.

Reported adverse events (FAERS/openFDA)#

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