FDA.reportPublic FDA data

FDA label c77d2e72-0d37-678e-e053-2995a90ad015

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
99a003b6-1633-43cc-a6f9-c536b0975f2b
SPL ID
c77d2e72-0d37-678e-e053-2995a90ad015
Version
7
Effective date
2021-07-19
Source export date
2026-08-08
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/1742e81476d3d6cada20c9e3894391dc6e407b1d0da716d0da13f6f74451bfd1/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 17:01:17

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 if you have kidney disease unless directed by a doctor 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 kidney disease a magnesium-restricted diet 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, as these may be 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