boxed warning
TAMPER EVIDENT PACKAGE Do not use if printed seal under cap is torn or missing.
FDA label 3f25c445-bbb0-2500-e063-6294a90aea41
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
- 5dddab8d-0041-4486-9ed9-1dbd13575b47
- SPL ID
- 3f25c445-bbb0-2500-e063-6294a90aea41
- Version
- 10
- Effective date
- 2025-09-19
- 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 06:08:10
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 | 3f25c445-bbb0-2500-e063-6294a90aea41 | id | |
| spl set id | 5dddab8d-0041-4486-9ed9-1dbd13575b47 | 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 CHOKING: taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention. 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 sensitivity to any of the ingredients Stop use and ask a doctor if you have rectal bleeding you fail to have a bowl movement after use. These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. When using this product do not exceed recommended maximum daily dose unless directed by a doctor do not use laxative products for a period longer than one week unless directed by a doctor
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.