FDA.reportPublic FDA data

Helleborus comp. E

Manufacturer
Uriel Pharmacy Inc.
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:29:41

Label at a glance#

ProductHelleborus comp. E
Active ingredientKALANCHOE DAIGREMONTIANA LEAF, ROSMARINUS OFFICINALIS FLOWERING TOP, ANTIMONY, GOLD, HELLEBORUS FOETIDUS ROOT, CHINESE YAM, HELLEBORUS NIGER ROOT, LEAD
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

Take 3-4 times daily. Ages 12 and older: 10 drops. Ages 2-11: 5 drops. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Bryophyllum (Life plant) 2X, Dioscorea batata (Chinese yam) 3X, Rosmarinus (Rosemary) 8X, Aurum (Metallic gold) 12X, Helleborus e pl. tota (Christmas rose) 12X, Plumbum mellitum (Lead with honey) 20X, Helleborus e fol. (Christmas rose) 21X, Stibium (Antimony) 30X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Distilled water, 20% Organic cane alcohol

Prepared using rhythmical processes.

OTC - PURPOSE SECTION

Use: Temporary relief of headache.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858
Made with care by Uriel, East Troy, WI 53120
shopuriel.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Helleborus comp. E LiquidHelleborus comp. E Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-5120-3Helleborus comp. E60 mL in 1 BOTTLE, DROPPERLIQUID603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-5120HELLEBORUS COMP. E LIQUID [URIEL PHARMACY INC.]3Legacy NDC, 1 package rows20241219_902ac093-cfb2-277f-e053-2995a90a8348.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-512048951-5120-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
KALANCHOE DAIGREMONTIANA LEAFL6X13JKL8OACTIB
ROSMARINUS OFFICINALIS FLOWERING TOP8JM482TI79ACTIB
ANTIMONY9IT35J3UV3ACTIB
WATER059QF0KO0RIACT
GOLD79Y1949PYOACTIB
HELLEBORUS FOETIDUS ROOT332Y7EES96ACTIB
ALCOHOL3K9958V90MIACT
CHINESE YAM29CIF30B1ZACTIB
HELLEBORUS NIGER ROOT608DGJ6815ACTIB
LEAD2P299V784PACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
297b6a01-c641-1cf9-e063-6394a90ad8f2902ac093-cfb2-277f-e053-2995a90a83482024-12-17WarningsExact identifier
spl id: 297b6a01-c641-1cf9-e063-6394a90ad8f2
spl set id: 902ac093-cfb2-277f-e053-2995a90a8348

Reported adverse events (FAERS/openFDA)#

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