FDA label 03b8464e-566d-41c9-93e9-41259b5b8bef

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
8a0c93a1-4378-4f6c-b4ec-256c0e59cf87
SPL ID
03b8464e-566d-41c9-93e9-41259b5b8bef
Version
5
Effective date
2017-05-24
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:47:43

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: Sore throat warning: If sore throat is severe, persists more than 2 days, is accompanied by a high fever, headache, rash, nausea, vomiting, or a rash, c onsult a doctor promptly. Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma or emphysema; a cough accompanied by excessive phlegm (mucus). Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 7 days, cough lasts more than 7 days or occurs with rash or persistent headache, fever worsens or lasts more than 3 day. These could be signs of a serious condition. If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children. In case of overdose, seek medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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