FDA label aaa60da3-0a8f-4499-b171-99d9ad73d87f

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
aea7062b-1472-429a-b1cf-56eed70dc8f1
SPL ID
aaa60da3-0a8f-4499-b171-99d9ad73d87f
Version
2
Effective date
2017-09-25
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:39:49

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 ofr if accompanied by a high gever, headache, nausea, vomiting or rash may be serious. Consult a physician promptly. Ask a doctor before use if you have: persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema, a cough accompanied by excessive phlegm (mucus). Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, cough lasts more than 7 days or occurs with rash or persistent headache, fever worsens or lasts more than 3 days. These could be signs of a serious condition. Keep out of Reach of Children: Keep out of reach of children. Ask the Doctor: 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 get worse or last more than 7 days, cough lasts more than 7 days or occurs with rash or persistent headache, fever worsens or lasts more than 3 days. These could be signs of a serious condition. Pregnancy or Breast Feeding: If pregnant or breast-feeding, ask a healthcare professional before use.

Reported adverse events (FAERS/openFDA)#

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