FDA label ccf5985f-7661-4602-99f3-2b623332f440

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: 8dce2ae1-e9dc-4694-8f4c-223558354f5e
SPL ID: ccf5985f-7661-4602-99f3-2b623332f440
Version: 2
Effective date: 2011-03-24
Source export date: 2026-11-06
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/d05434af5edc4383b7c7894a8f2d94df21171d17714450933cecdfc35cedfa3d/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 06:43:56

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		ccf5985f-7661-4602-99f3-2b623332f440	id
spl set id		8dce2ae1-e9dc-4694-8f4c-223558354f5e	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 do not use when abdominal pain, nausea, or vomiting are present unless directed by a doctor for more than 1 week unless directed by a doctor. Ask a doctor before use if you 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 can be signs of a serious condition. If pregnant of breast feeding Ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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