FDA label 38b27a93-20ef-49a1-b70a-4272f7a94813

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
ec137bc1-0db2-43ab-9c79-51d9df67888e
SPL ID
38b27a93-20ef-49a1-b70a-4272f7a94813
Version
4
Effective date
2016-12-23
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 02:23:59

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 cannot swallow without chewing. Ask a doctor before use if you have ■ abdominal pain, nausea or vomiting ■ a sudden change in bowel habits that persists over a period of 2 weeks When using this product ■ do not chew or crush ■ do not take this product within 1 hour of taking antacid or milk ■ you may have stomach discomfort, faintness or cramps Stop use and ask a doctor if ■ rectal bleeding or failure to have a bowel movement after use of a laxative These could be signs of a serious condition. ■ you need to use a laxative for more than 1 week Pregnancy/Breastfeeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children Keep out of reach of children. In case of accidental overdose, get medical help or contact a doctor or Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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