FDA label 423691f9-9ab1-fad0-e063-6394a90a8d1b

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
03eeca55-f239-4a01-a900-c1943f27a834
SPL ID
423691f9-9ab1-fad0-e063-6394a90a8d1b
Version
7
Effective date
2025-10-28
Source export date
2026-11-06
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/2026-11-06/97001096994db9ca8cee114e6c3bb5298d3c573158ffc1ab8692d82e76a3eb40/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 06:56:27

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 for children under 6 years of age. Ask a doctor before use if you have abdominal pain nausea vomiting a sudden change in bowel habits that lasts more than 2 weeks When using this product do not chew or crush tablet do not use within 1 hour after taking an antacid or milk abdominal discomfort, faintness and cramps may occur Stop use and ask a doctor if you need to use a laxative for more than 1 week rectal bleeding or failure to have a bowel movement after use of laxative. These could be signs of a serious condition. If pregnancy 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 at (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

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