FDA label 5a2324da-1fdc-540c-e063-6294a90a2cab
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
- 1ab92efb-ae5a-b71c-e063-6294a90a60d1
- SPL ID
- 5a2324da-1fdc-540c-e063-6294a90a2cab
- Version
- 3
- Effective date
- 2026-08-28
- Source export date
- 2026-09-28
- 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/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:18:41
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 | 5a2324da-1fdc-540c-e063-6294a90a2cab | id | |
| spl set id | 1ab92efb-ae5a-b71c-e063-6294a90a60d1 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS AND PRECAUTIONS: Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breastfeeding. Consult your doctor. ADVERSE REACTIONS: Adverse reactions are rare but may include gastrointestinal disturbances such as nausea or constipation. If adverse reactions occur, discontinue use and consult a healthcare professional. You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact PureTek Corporation , at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: Adverse reactions are rare but may include gastrointestinal disturbances such as nausea or constipation. If adverse reactions occur, discontinue use and consult a healthcare professional. You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact PureTek Corporation , at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.