FDA label e3a8d96b-12f2-485e-9ee4-cda63df56524

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
dedd48c5-e030-4214-9747-a55ad69af35a
SPL ID
e3a8d96b-12f2-485e-9ee4-cda63df56524
Version
4
Effective date
2023-04-04
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:39:02

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings Do not use if presence nausea, vomiting, rectal bleeding, or in children under 5 years of age or for more than one week unless directed by a doctor. Use of this product may cause abdominal discomfort, faintness, rectal burning and mild cramps. Stop use and ask a doctor If rectal bleeding occurs or if you fail to have a bowel movement after using a laxative. This may indicate a serious condition. Ask a doctor before use If pregnant or breast feeding, or if a sudden change in bowel habits persists for more than two weeks. Frequent or continued use of this product may result in dependence on laxatives. DRUG FACTS (continued) Keep this and all medication out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

warnings

Warnings Do not use if presence nausea, vomiting, rectal bleeding, or in children under 5 years of age or for more than one week unless directed by a doctor. Use of this product may cause abdominal discomfort, faintness, rectal burning and mild cramps. Stop use and ask a doctor If rectal bleeding occurs or if you fail to have a bowel movement after using a laxative. This may indicate a serious condition. Ask a doctor before use If pregnant or breast feeding, or if a sudden change in bowel habits persists for more than two weeks. Frequent or continued use of this product may result in dependence on laxatives. DRUG FACTS (continued) Keep this and all medication out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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