FDA label aff770c8-9980-43f7-b95a-3958364aa3a0

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
e69c7cb7-b7da-425b-8f76-1424c8ad0a37
SPL ID
aff770c8-9980-43f7-b95a-3958364aa3a0
Version
6
Effective date
2018-10-19
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:06:31

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 if you are unable to swallow without chewing. 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 When using this product abdominal discomfort, faintness, and cramps may occur do not use for a period longer than 1 week unless directed by a doctor Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement occurs after use of a laxative. These may be signs of a 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 (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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