FDA.reportPublic FDA data

FDA label 47cdd4ae-3fcd-2ca4-e063-6294a90a8010

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
c45c1dba-ba6c-4dfb-a1ee-c5ec61ad4dfb
SPL ID
47cdd4ae-3fcd-2ca4-e063-6294a90a8010
Version
2
Effective date
2026-01-07
Source export date
2026-08-01
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/0689a4374f1490600b5244071db3b04bd3bbc29ceda7a856edb8225323adf20a/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 22:59:33

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 Do not use If you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have Liver or kidney disease. Your doctor should determine if you need a different dose. When using this product Do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if An allergic reaction to this product occurs. Seek medical help right away. 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.