FDA.reportPublic FDA data

FDA label 49f1209f-34dd-ddae-e063-6394a90a633f

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
615422e9-e1cf-43bc-bd22-532c0d90858f
SPL ID
49f1209f-34dd-ddae-e063-6394a90a633f
Version
16
Effective date
2026-02-03
Source export date
2026-11-06
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/2026-11-06/10387d7618367cd955339e75d48af3d11f99f789153db05c529d9fad6eccc645/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:18:07

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 for external use only Do not use in the eyes or apply over large areas of the body longer than 1 week Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns Stop use and ask a doctor if the condition persists or gets worse sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash, or fever develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTION DISTRIBUTED BY DEMOULAS SUPER MARKETS, INC. 875 East Street, Tewksbury, MA 01876 Pat. D675, 101

Reported adverse events (FAERS/openFDA)#

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