FDA label da2da956-c05f-4138-9a1c-5cd3f847ca24

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
57931e5f-f0c5-4b0d-ae82-3e11a873e1ac
SPL ID
da2da956-c05f-4138-9a1c-5cd3f847ca24
Version
2
Effective date
2025-09-17
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:25:19

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. Do not use laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor Ask a doctor before using any laxative if child has • abdominal pain, nausea or vomiting. • a sudden change in bowel habits lasting more than 2 weeks. • already used a laxative for more than 1 week. When using this product rectal discomfort or burning sensation may occur Stop use and consult a doctor if child has • rectal bleeding • no bowel movement within 1 hour of using this product This may indicate a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right immediately (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

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