FDA label 74865610-8987-7f54-e053-2991aa0a967a

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
ed61f05b-7331-4679-bf94-e5edbaae4cfd
SPL ID
74865610-8987-7f54-e053-2991aa0a967a
Version
5
Effective date
2018-08-28
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:23:11

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

Do not use if you have a medical condition or are taking any prescription medication(s) use if you have severe liver, gallbladder or kidney problems use if you are taking certain medications such as digoxin (used for congestive heart failure), phenytoin (for seizures), anticoagulants or others use in patients with megacolon, as hypernatremic dehydration may occur. Use with caution in patients with impaired renal functions exceed the label dose unless directed by a doctor use more than once a month on a regular basis as the diuretic effect may deplete the body of essential water soluble vitamins and minerals over time

Reported adverse events (FAERS/openFDA)#

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