FDA label 646b991a-d1ab-4c00-9e5a-4d8db83e2993

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
a5ea0a61-bc61-45b5-90e1-37baa5326117
SPL ID
646b991a-d1ab-4c00-9e5a-4d8db83e2993
Version
2
Effective date
2018-06-20
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:48:43

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 If pregnant or breast-feeding, ask a health professional before use. This package is intended for institutional use only. This unit dose package is not child-resistant. If dispensed for outpatient use, a child-resistant container should be utilized. Do not use laxative products for more than 1 week unless directed by a doctor. Ask a doctor before use if you have stomach pain, nausea, vomiting or have noticed a sudden change in bowel habits that persists over a period of 2 weeks. Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. TAMPER-EVIDENT: Each tablet is individually sealed. Do not use if blister or foil is broken, torn, or missing. Questions? Call 1-888-838-2872, weekdays, 8 am - 5 pm Eastern Time

Reported adverse events (FAERS/openFDA)#

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