FDA.reportPublic FDA data

FDA label fa852297-5b7c-4e87-9bc5-a91cea72116f

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
a4852d9d-5f9f-4139-9467-b81b5c3a8f5a
SPL ID
fa852297-5b7c-4e87-9bc5-a91cea72116f
Version
2
Effective date
2020-07-03
Source export date
2026-08-17
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-17/1428ecb25c316753060ea7ddb566e8693893fa6e325c185f8717828825c2afb3/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run
20260818T065550Z
Imported at
2026-08-18 08:36:43

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 for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious. Stop use and ask a doctor if • sore mouth does not improve in 7 days • irritation, pain or redness persists or worsens