FDA label a69fa8ca-e25d-49a5-be65-a4dbe6a36375

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
d6ad5ea6-4228-424b-bd3a-edeb0c72e2c7
SPL ID
a69fa8ca-e25d-49a5-be65-a4dbe6a36375
Version
2
Effective date
2018-04-10
Source export date
2026-08-01
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/5a565ce64c898c83223b815b9579cd46fb0c6d54977c3cace2133e40124f7fbb/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:08:45

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 Dosage warning: Using more than one enema in 24 hours can be harmful. Ask a doctor before use if you have • a sodium-restricted diet • abdominal pain, nausea or vomiting • kidney disease, heart problems, or are dehydrated • noticed a sudden change in bowel habits that lasts over 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work. When using this product do not use • more than directed. Serious side effects may occur from excess dosage. • do not use for more than 3 days Stop use and ask a doctor if • you have rectal bleeding • you have no bowel movement after use of a laxative These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)