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 (canonical bytes are SHA-256 checked before publication)

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

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 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#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

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.