FDA label bc82778e-46c6-4bc3-86f8-c6209faeb8bf

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
eed05b38-4133-44c4-9b3e-81a04555a218
SPL ID
bc82778e-46c6-4bc3-86f8-c6209faeb8bf
Version
1
Effective date
2010-04-21
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 06:22:16

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 Stomach pain nausea vomiting noticed a sudden change in bowel habits that persists over a period of 2 weeks When using this product do not chew or crush tablets do not take this product within 1 hour after taking an antacid or milk it may cause stomach discomfort,faintness, and cramps Stop use and ask doctor if you need to use more than 1 week rectal bleeding or failure to have a bowel movement occur after use of a laxative.These may be signs of a serious condition If pregana 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.

Reported adverse events (FAERS/openFDA)#

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