FDA label 7cceda8a-2bff-b286-e053-2a91aa0a0c4b

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
7cceda8a-2bfe-b286-e053-2a91aa0a0c4b
SPL ID
7cceda8a-2bff-b286-e053-2a91aa0a0c4b
Version
1
Effective date
2018-12-12
Source export date
2026-09-28
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:29:00

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

1) Do not take this medicine. (1) Patients with hypersensitivity reactions to NSAIDs and the components contained in NSAIDs (2) Infants under three months of age (3) Because this drug contains lactose, patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption Do not administer. 2) Do not take the following medicine while taking this medicine. (1) levodopa 3) Consult a doctor, dentist or pharmacist before taking this medicine. (1) Patients receiving medical treatment (2) patients with hyperoxaluria (excessive urinary excretion of urine) (3) Pregnant women and possibly pregnant women, lactating women, premature infants, infants (4) Patients with gout or kidney stones 4) Stop taking this drug immediately and consult a doctor, dentist, or pharmacist if you: Whenever possible, bring this attached document with you. (1) If you have any of the following symptoms Stomach discomfort, diarrhea, constipation, rash, fever, nausea, vomiting, dilated stool, stomatitis (mouth salt), anorexia, abdominal bloating (2) Administration of this drug may result in faster or more frequent menstruation, and bleeding may last for a long time. (3) The risk of thrombosis may be increased if a woman taking an oral contraceptive containing estrogen or a patient with thrombotic placenta is taking vitamin E. (4) Long-term administration of high doses may result in resistance. (5) Prolonged use of pyridoxine at a dose of 500 mg to 2 g / day may result in neuropathy or neuropathy (functional disorder or pathologic changes) in the peripheral nervous system. (6) Hematologic adverse events may occur when vitamin B12 is administered at a dose of 10 μg or more per day in patients with insufficient folic acid. 5) Other Precautions for Taking (1) Keep the prescribed dosage and dosage. (2) it may interfere with the detection of blood glucose during various urine tests (3) The urine may turn yellow, which may affect the clinical examination 6) Storage Precautions (1) Keep out of the reach of children. (2) Avoid direct sunlight. Store in a cool, dry place. (3) To prevent misuse (misuse) and to preserve quality, please do not put in another container.

Reported adverse events (FAERS/openFDA)#

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