FDA label b11f4b16-f65f-4b3f-88d2-ae8549bc7abb

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
bc2eaeb2-742b-44e4-92c3-718f89c842b5
SPL ID
b11f4b16-f65f-4b3f-88d2-ae8549bc7abb
Version
2
Effective date
2018-12-27
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:00:15

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 in children under 6 years of age Ask a doctor before use if you have abdominal pain nausea vomiting noticed a sudden change in bowel habits that persists over a period of 2 weeks Ask a doctor or pharmacist before use if you are unable to swallow without chewing When using this product do not chew or crush tablets 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 more than 1 week rectal bleeding or failure to have a bowel movement occurs after use of a laxative. These maybe signs of serious condition. 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: 1-800-222-1222

Reported adverse events (FAERS/openFDA)#

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