FDA label 0cfed9d3-9cbe-71f2-e063-6394a90aa3ca

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
781d53cf-b3db-3e2b-e053-2a91aa0a7dcd
SPL ID
0cfed9d3-9cbe-71f2-e063-6394a90aa3ca
Version
5
Effective date
2023-12-20
Source export date
2026-09-28
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:43:32

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings For external use only. Do not that by mouth or place in nostrils. Flammable . Keep away from fire or flame

warnings

WARNINGS: KEEP OUT OF REACH OF CHILDREN. NOT RECOMMENDED FOR CHILDREN UNDER 12. CONSULT A DOCTOR BEFORE USE: WITH MEDICATIONS OR BLEEDING OR BLEEDING DISORDERS IF SYMPTOMS PERSIST/WORSEN DO NOT USE: WHILE TRYING TO CONCEIVE, OR WHILE PREGNANT/BREASTFEEDING. WHILE TAKING INSULIN, ORAL DIABETIC MEDICATIONS, GINSENG, OR OTHER MEDICATIONS / HERBS THAT MAY LOWER BLOOD SUGAR WITH TUBERCULOSIS, LEUKOSIS, COLLAGENOSIS, MS, HIV/AIDS, AUTOIMMUNE DISORDERS, OR OTHER PROGRESSING SYSTEMIC DISEASES IF TAKING MEDICATIONS THAT MAY AGGRAVATE ELECTORLYTE IMBALANCE, INCLUDING DIURETICS, CARDIAC GLYCOSIDES, AND CORTICOSTEROIDS WITH HYPERTONIA (MUSCULAR RIGITDITY, TENSION, AND SPASMS), HYPERKALEMIA (EXCESSIVE POTASSIUM IN THE BLOOD) HIGH BLOOD PRESSURE, HEART DISORDERS, OR SEVERE OBESITY WITH KIDNEY, LIVER, OR BILE FLOW DISORDERS. MAY CAUSE LIVER OR KIDNEY DAMAGE; DISCUSS SIDE EFFECTS WITH YOUR DOCTOR IF ALLERGIC TO PLANTS OF THE ASTERACEAECOMPOSITAE/DAISY FAMILY. STOP USE IF ALLERGIC REACTION OCCURS CONTAINS NATURALLY OCCURING GLYCYRRHIZIN FROM LICORICE ROOT. OVERCONSUMPTION OF GLYCYRRHIZIN FROM LICORICE ROOT CAN CAUSE BODY'S POTASSIUM LEVELS TO FALL, POSSIBLY RESULTING IN ABNORMAL HEART RHYTHMS/HIGH BLOOD PRESSURE/EDEMA (SWELLING)/LETHARGY/CONGESTIVE HEART FAILURE.

Reported adverse events (FAERS/openFDA)#

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