FDA label c4ae7c1e-7739-4500-bd62-e0e7a59dfee5

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
7f3bfdef-768c-4b82-8f03-0a3d842d43a9
SPL ID
c4ae7c1e-7739-4500-bd62-e0e7a59dfee5
Version
5
Effective date
2019-05-08
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:21:53

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 are unable to swallow without chewing. Ask a doctor before use if you have abdominal pain nausea vomiting noticed a sudden change in bowel habits that persists over a period of 2 weeks When using this product abdominal discomfort, faintness, and cramps may occur do not use for a period longer than 1 week unless directed by a doctor Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement occurs after use of a laxative. 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 (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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