FDA label e3d37ded-b7a9-4880-a75e-7ffaea4eeabf

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
d8d0c482-8802-433f-833e-1cfec874e2b9
SPL ID
e3d37ded-b7a9-4880-a75e-7ffaea4eeabf
Version
12
Effective date
2023-07-11
Source export date
2026-09-28
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/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:16:17

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 for more than 2 days of if accompanied by high fever, headache, nausea, vomiting or rash may be serious. Consult a physician promptly. Ask Doctor Ask a doctor before use if you have a persistent or chronic cough that lasts, is chronic such as occurs with asthma, chronic bronchitis, or emphysema or is accompanied by excessive phlegm (mucus). Stop Use Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better in 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache. These could be signs of a serious condition. Pregnancy or Breast Feeding If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children Keep out of reach of children Overdose In case of overdose, seek medical help or contact a Posion Control Center immediatley.

Reported adverse events (FAERS/openFDA)#

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