boxed warning
Caution: Do not use if imprinted seal under cap is broken or missing.
FDA label 45d30503-3fa6-fe18-e063-6394a90a0d63
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
- SPL set ID
- ec9edf75-b9cc-0b99-e053-2995a90a391f
- SPL ID
- 45d30503-3fa6-fe18-e063-6394a90a0d63
- Version
- 3
- Effective date
- 2025-12-13
- Source export date
- 2026-11-06
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/2233cb6af8c6b55a5e4a05449e8db0d2f259f3c061d5d001b654a8bea1cc1db2/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 07:52:53
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 45d30503-3fa6-fe18-e063-6394a90a0d63 | id | |
| spl set id | ec9edf75-b9cc-0b99-e053-2995a90a391f | set_id |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Warnings Do not use if you cannot swallow without chewing Ask a doctor before use if you have: stomach pain, nausea, or vomiting noticed a sudden change in bowel habits that lasts more than 2 weeks When using this product it may cause stomach discomfort, faintness and cramps do not chew or crush tablets(s) do not use within 1 hour after taking antacid or milk Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition. you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health care professional before use.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.