FDA label 44014fd2-c912-83d5-e063-6394a90a008a

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
859906f4-7ad9-e41f-e053-2a91aa0ab1b8
SPL ID
44014fd2-c912-83d5-e063-6394a90a008a
Version
2
Effective date
2025-11-20
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:14:44

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. Do not take to infants (infants, babies) under 3 months. In addition, infants (infants and young babies) who are under the age of one for at least three months must give priority to receiving medical attention, and should not be taken unless they are inevitable. 2. Consult a doctor, dentist or pharmacist before taking this medicine. 1) patients with hypertension, elderly (elderly), cardiac or renal (kidney) patients, edema (swelling) patients 2) People who are taking other medicines: potassium-containing preparations, licorice-containing preparations, glycyrrhizic acid or its salt-containing preparations, loop-type diuretics (furosemide, ethacrynic acid) or thiazide diuretics (trichloromethiazide) (Combined with) Aldosteronism or hypokalemia due to myocarditis (myopathy) is likely to occur due to taking it carefully. 3) Patients receiving medical treatment 3. Immediately stop taking this drug and consult a doctor, dentist or pharmacist if: Have this attached document at the time of consultation. 1) Upper aldosteronism: If you have decreased urine volume, face and hands and feet are swollen, your eyelids are getting heavy, your hands are hardening, your blood pressure is getting high or you have a headache (such as a maximum dose of 1g per day as a licorice, Observation (measurement of serum potassium levels) should be sufficient and should be discontinued if abnormality is confirmed, because gastric aldosteronism such as elevation of blood pressure, elevation of blood pressure, retention of sodium body fluid (swelling), swelling (swelling) 2) Myopathy (myopathy): As a result of hypokalemia, myopathy (myopathy) may occur. If the observation is sufficient and anomalies such as helplessness, cramps and paralysis are confirmed 3) If there is no improvement in symptoms even for several days 4. Other cautions when taking this medicine 1) Keep the prescribed dosage and dosage. 2) When taking a child, take it under the supervision of a guardian. 3) Do not take it for a long time. 5. Storage Precautions 1) Keep out of reach of children. 2) Taking medicines out of their original containers and storing them in other containers may cause accidents or poor quality of medicines due to misuse (misuse), so keep them in their original container and keep them tightly closed. 3) Avoid direct sunlight and store in a cool, dry place.

Reported adverse events (FAERS/openFDA)#

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