FDA label 61f4eb7d-b61b-4c69-8350-19977def7b50

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
61f4eb7d-b61b-4c69-8350-19977def7b50
SPL ID
61f4eb7d-b61b-4c69-8350-19977def7b50
Version
2
Effective date
2014-10-30
Source export date
2026-10-22
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-22/1e745e0906b899af47c88f3dead6beee5ae51229b555f30f1c85dfc349b0fede/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
5de9d3c3492926d1703b492ae4d29b036ac5be73edfcb92a6cd5eb95a2acef9c
Import run
20261023T001338Z
Imported at
2026-10-23 01:25:40

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 For rectal use only Ask a doctor before use if you have • abdominal pain, nausea or vomiting • notice a sudden change in bowel habits that persists over a period of 2 weeks Stop use and ask a doctor if • you have rectal bleeding or failure to have a bowel movement after use of a laxative because this may indicate a serious condition • you need to use a laxative for more than one week If pregnant or breastfeeding, 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.