FDA label df0a770a-eddd-4adc-96db-02da3cf01657

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
458f701f-6f74-46c7-a801-6669cbf1b5b5
SPL ID
df0a770a-eddd-4adc-96db-02da3cf01657
Version
2
Effective date
2019-12-23
Source export date
2026-09-28
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:13:59

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 Do not use if you cannot swallow without chewing Ask a doctor before use if -you have a sudden change in bowel habits that lasts more than 2 weeks -stomach pain, nausea or vomiting When using this product -do not use within 1 hour after taking an antacid or milk -do not chew or crush tablet(s) -you may have stomach discomfort, faintness or cramps Stop use and ask a doctor if -you have rectal bleeding or fail 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 ask a health professions before use. Keep out of reach of children 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.