FDA label 1b8cf3bb-81e9-adce-e063-6294a90a763a

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
80dec6c1-12fb-94f0-e053-2991aa0ae10a
SPL ID
1b8cf3bb-81e9-adce-e063-6294a90a763a
Version
6
Effective date
2024-06-23
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 05:16:02

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 Oral use only Use only recommended dosage and administration Do not use if the user • is under 5 years old • has galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, or hereditary illness/ disease. Ask a doctor, pharmacist, or dentist before use if the user have (is) • high blood pressure (hypertension) • heart disease • kidney disease • edema • weak constitution • stomach disorder • previously experienced drug allergies (e.g., rash, skin redness, skin irritation, etc.) • doctor’s treatment, undergoing therapy, or taken other medication • aged person • please use it with caution, this product contains dye Yellow No. 5 (Sunset Yellow FCF). Individuals who are sensitive or have a history of allergy to this ingredient. When using this product • use only recommended dosage and administration • not recommended long-term use, but if you take this product with long-term ask doctor, pharmacist, or dentist. • children should take this medication under the guidance of their parents • together with preparations containing potassium, licorice components, glycyrrhizic acid (or its salt), or loop diuretics (e.g., furosemide and ethacrynic acid), or thiazide diuretics (e.g, trichlormethiazide), muscle disorders caused by pseudoaldosteronism and hypokalemia may readily occur. Please use it with caution. • together with any other herbal medicine, please use it with caution and avoid the overlapping ingredients. Stop use and ask a doctor, pharmacist, or dentist if • occurrence of reduced urine output, swelling of the face or limbs, heavy eyelids, stiffness of hands, high blood pressure or headache, and other symptoms after taking this product. • Pseudo aldosterone disease: When individuals are in long-term use of the preparation of which the daily dose of licorice is over 1g, symptoms of pseudoaldosteronism, such as hypokalemia, increased blood pressure, sodium and water retention, edema, and weight gain, may occur. After a full observaion (e.g., determination of serum potassium concentration), • Myopathy (muscle disorders): Hypokalemia may lead to muscle diseases. • fatigue, spastic quadriplegia, or paralysis are confirmed through a full observation. • rash, skin redness, nausea, vomiting, loss of appetite, difficulty in urination, vertigo, etc., occur • urticaria, swollen throat, eyelids, lips, and other parts, chest congestion accompanied by paleness, cold limbs, cold sweats, shortness of breath, etc. • there is no remission of symptoms after several dosages If pregnant or breast-feeding, ask doctor, or health professional before use. Store at cool temperature and dry place with a closed container. Avoid direct sunlight. - Store in a container other than its original container is equivalent to misuse. In order to prevent the reduction of drug efficacy, keep the product in its original container for storage.

Reported adverse events (FAERS/openFDA)#

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