FDA label af396b3b-1a05-4f45-9ab7-8f05df8d1b6f

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
296659f8-ce44-453e-b245-bd8ae215e012
SPL ID
af396b3b-1a05-4f45-9ab7-8f05df8d1b6f
Version
3
Effective date
2018-12-17
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:05:14

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 Do not use if abdominal pain, nausea, or vomiting are present Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks you are presently taking mineral oil Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement occur after use which may indicate a serious condition you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

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