FDA.reportPublic FDA data

FDA label 64417ad8-dd57-4c58-973c-97416ec4219a

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
9ad6c4ef-6ae6-4228-a625-02d5548da486
SPL ID
64417ad8-dd57-4c58-973c-97416ec4219a
Version
2
Effective date
2019-05-23
Source export date
2026-10-12
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/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:41:11

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 • laxative products for longer than 1 week unless directed by a doctor Ask a doctor or pharmacist before use if you have • stomach pain • nausea • vomiting • notice a sudden change in bowel movement that continues over a period of 2 weeks Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement after use of laxative. These may indicate a serious condition If pregnant or breast-feeding, ask a health professional before use

Reported adverse events (FAERS/openFDA)#

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