FDA label 5f71be45-4e63-4779-9b07-ff182d35b865

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
da9cbc16-3c30-4088-8b48-06d3ded21b25
SPL ID
5f71be45-4e63-4779-9b07-ff182d35b865
Version
2
Effective date
2017-05-17
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:29:44

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: Consult a doctor if symptoms worsen, do not improve within 7 days, or new symptoms appear. If fever lasts more than 3 days, or if sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, difficulty breathing, headache, rash, swelling, nausea, or vomiting, consult a doctor. If cough persists for more than 7 days, tends to recur, or is accompanied by a rash or persistent headache, consult a doctor. A persistent cough may be a sign of a serious condition. Do not take this product for persistent 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. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

Reported adverse events (FAERS/openFDA)#

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