FDA.reportPublic FDA data

FDA label 375beaeb-34bd-448d-e054-00144ff8d46c

openFDA label record#

Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
5ff31815-44b8-4d3d-92b2-541bc49b5283
SPL ID
375beaeb-34bd-448d-e054-00144ff8d46c
Version
2
Effective date
2016-07-11
Source export date
2026-08-01
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/286b06ef66f7efdb8cdf48688678b429950d1b94558fe44fcd6cc6eb20c2100b/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:05:33

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 if you have ever had an allergic reaction to this product or any of its ingredients liver or kidney disease. Your doctor should determine if you need a different dose. do not take more than directed. Taking more than directed may cause drowsiness. an allergic reaction to this product occurs. Seek medical help right away. ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)