FDA label 8842d2b2-6eda-4a29-a50e-81071143b96c

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
978dd69b-c349-485b-bdf3-672b97890dcc
SPL ID
8842d2b2-6eda-4a29-a50e-81071143b96c
Version
2
Effective date
2018-04-11
Source export date
2026-10-12
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:42:47

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 health professional before use. TAMPER EVIDENT: DO NOT USE IF A BLISTER UNIT IS TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. Do not chew tablets, do not give to children under 6 years, do not give to persons who cannot swallow without chewing, do not take within 1 hour after taking antacid or milk. Ask a doctor before use if you have abdominal pain, nausea, vomiting or a sudden change in bowel movements that persist over a period of 2 weeks. When using this product: do not use for a period longer than 1 week unless directed by a doctor; you may experience abdominal discomfort, faintness and cramps. Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement within 12 hours.

Reported adverse events (FAERS/openFDA)#

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