FDA.reportPublic FDA data

FDA label d6b42df2-367b-451f-ae83-302b6d2f66d7

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
be097aef-eb1d-4ccd-8633-e6f21ce8707a
SPL ID
d6b42df2-367b-451f-ae83-302b6d2f66d7
Version
4
Effective date
2019-10-30
Source export date
2026-08-17
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/2026-08-17/2761da4658ad131439428ba873b36a73954aaa035ff81deb66240a9db091dbf8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run
20260818T065550Z
Imported at
2026-08-18 08:20:59

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: Severe or persistent sore throat or sore throat that occurs with high fever, headache, nausea, and vomiting may be serious. Ask a doctor right away. Do not use more than 2 days or give to children under 3 years of age. When using this product, do not use more than directed. Stop use and ask a doctor if swelling, rash or fever develops irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days difficulty in breathing occurs If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.