FDA label 972ca92a-41a9-712a-e053-2995a90a4926

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
970b0ada-66d3-74fc-e053-2a95a90aee83
SPL ID
972ca92a-41a9-712a-e053-2995a90a4926
Version
2
Effective date
2019-11-12
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 06:23:37

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

WARNING Do not take if you have ■a headache, a chill, or fever with the symptom ■an abscessus frigidus(cold abscessus), or a chronic abscess. ■galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption (this medicine contains lactose) Ask a health professional before use it if you ■have high blood pressure ■have a problem with heart or kidney ■have edema ■are on other medication ■are pregnant, breast feeding, or have chance to get pregnant ■have a history of allergic reaction to medicines ■are under 12 ■are sensitive or have a history of allergic reaction to Food Yellow No. 5 (Sunset Yellow FCF) Stop using and ask doctor ■If you have following symptom ■pseudoaldosteronism: reduce in urine volume, stiffness of hand, have swollen hands and feet, heavy feelings in eye lids, high blood pressure, or headache (taking Licorice more than 1 g a day for long period might cause symptoms of pseudoaldosteronism such as hypokalemia, rise in blood pressure, or low flow of sodium.) ■myopathy: if feeling impuissance side effect from Hypokalemia such as convulsion or numbness ■skin trouble: a rash, flare, or pruritus ■feeling discomfort on upper stomach ■ if symptoms persist after 5~6 days of using. When using this product ■ using for long term is not recommended, but if needed, ask a health professions. ■ Do not exceed the recommended dosage Keep out of reach of Children Other information ■ keep in dry and cool area, out of direct sunlight if possible ■ Keep this label and enclosed materials in the box. They contain important information and putting in other container may cause misuse.

Reported adverse events (FAERS/openFDA)#

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