FDA label b7aec228-5205-45a3-a794-d761edcc8ba5

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
d7560c7f-9366-4e09-ac24-7097f24f0746
SPL ID
b7aec228-5205-45a3-a794-d761edcc8ba5
Version
4
Effective date
2020-01-23
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:26:01

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 may be signs of a serious condition. If pregnant or breastfeeding, 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)

Reported adverse events (FAERS/openFDA)#

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