FDA label 368fe909-db2f-a065-e063-6294a90acd51

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
96e0edae-dbe7-50e8-e053-2995a90ac68a
SPL ID
368fe909-db2f-a065-e063-6294a90acd51
Version
3
Effective date
2025-06-02
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:29:34

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

Do not take this medicine if ■ people who are hypersensitive to the drugs and ingredients contained in this medicine Consult a doctor, dentist, or pharmacist before taking this medicine ■ Patients who are overreacting to substrates of azoic pigment, acetyl salicylic acid or other prostaglandin syncase inhibitors should be careful about the use of this drug ■ Be careful because this drug may interfere with the absorption of cholesterol medicines. ■ Pregnancy and lactation (for pregnant women or wives who are likely to be pregnant, only if the therapeutic benefit exceeds the risk) ■ Since this drug contains yellow 4 (tartrazine), consult a doctor, dentist, or pharmacist before taking it (for that item only) Immediately stop taking this medicine and consult a doctor or pharmacist if: ■ the drug is administered to patients with asthma or chronic stomatosis or is overreacting to non-steroidal anti-inflammatory drugs, it may cause anaphylaxis or respiratory system to overreact

Reported adverse events (FAERS/openFDA)#

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