FDA label 1678fd7f-ca8f-47c9-9cf5-81e95a9dbc21

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: 4d00384f-322b-4f52-85ad-a0b30e9e2ae5
SPL ID: 1678fd7f-ca8f-47c9-9cf5-81e95a9dbc21
Version: 9
Effective date: 2020-05-25
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 02:05:46

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		1678fd7f-ca8f-47c9-9cf5-81e95a9dbc21	id
spl set id		4d00384f-322b-4f52-85ad-a0b30e9e2ae5	set_id

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 This Unit Dose package is not child resistant and is Intended for Institutional Use Only. 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. For rectal use only. Do not use laxative products when abdominal pain, nausea, or vomiting are present. Do not use laxative products for a period longer than one week unless directed by a doctor. Stop use and ask a doctor if -rectal bleeding occurs -you fail to have a bowel movement after using a laxative. These may be signs of a serious condition.

Reported adverse events (FAERS/openFDA)#

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