FDA label cebb023f-1b63-405a-b256-bab75c5c05f3

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
7b9b0e4b-0511-414e-9163-c5317474cf18
SPL ID
cebb023f-1b63-405a-b256-bab75c5c05f3
Version
3
Effective date
2015-07-02
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:32:51

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.