FDA label 791463b1-5465-cd0d-e053-2a91aa0a3a8b

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: 8adc1cd7-0b18-4231-a78e-821e5200e5c6
SPL ID: 791463b1-5465-cd0d-e053-2a91aa0a3a8b
Version: 8
Effective date: 2018-10-25
Source export date: 2026-09-28
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:16:52

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		791463b1-5465-cd0d-e053-2a91aa0a3a8b	id
spl set id		8adc1cd7-0b18-4231-a78e-821e5200e5c6	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 for more than 1 week unless directed by a doctor Ask a doctor before use if you -have abdominal pain, nausea or vomiting -are taking mineral oil -have noticed a sudden change in bowel habits that lasts over 2 weeks Stop use and ask a doctor if -you have no bowel movement within 12 hours -you have rectal bleeding. these could signs of a serious condition. if pregnant or 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.