FDA label 6ed92ec9-ffab-4736-86ef-5ca07e3b20aa

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
c1445b48-96d7-430c-9735-5eeb32e575b7
SPL ID
6ed92ec9-ffab-4736-86ef-5ca07e3b20aa
Version
4
Effective date
2011-11-01
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:29:25

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 or is followed by high fever, headache, rash, swelling and nausea may be serious. Ask doctor right away. Do not use more than 2 days or give to children under 2 years of age unless directed by a doctor. Ask a doctor before use if you have cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops cough lasts more than 7 days, comes back, or occurs with fever, or persistent headache. These could be signs of a serious condition. 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 right away.

Reported adverse events (FAERS/openFDA)#

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