FDA.reportPublic FDA data

FDA label 7cdd8002-53e2-41df-a7df-d3bc66075d8a

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
7b925e5a-bae9-49d8-a3f6-b56e957d8d21
SPL ID
7cdd8002-53e2-41df-a7df-d3bc66075d8a
Version
5
Effective date
2018-04-10
Source export date
2026-08-01
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/054d07cb7b0dcd436e53c5bdecbb921b48860de8ff372c4a586941aa9821a276/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:20:35

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 This package is intended for institutional use only. If pregnant or breast-feeding, ask a doctor before use. Do not use if you cannot swallow without chewing Ask a doctor before use if you have stomach pain, nausea or vomiting or a sudden change in bowel habits that lasts over 2 weeks. When using this product do not chew or crush tablet(s), do not use within 1 hour after taking an antacid or milk. When using this product you may have stomach discomfort, faintness or cramps. Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may be signs of a serious condition. Stop use and ask a doctor if you need to use a laxative for more than 1 week. If pregnant or breast-feeding, ask a health professional before use.