FDA.reportPublic FDA data

Helleborus comp. C

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. C
Active ingredientSILVER, LEAD, CHELIDONIUM MAJUS, FORMICA RUFA, BOS TAURUS SPLEEN, HELLEBORUS NIGER ROOT, ANTIMONY
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE.

DOSAGE & ADMINISTRATION SECTION

Take the contents of one ampule under the tongue and hold for 30 seconds, then swallow.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Chelidonium (Greater celandine) 4X, Formica (Red wood ant) 6X, Lien (Bovine spleen) 8X, Helleborus niger (Christmas rose) 12X, Stibium (Antimony) 12X, Argentum (Silver) 20X, Plumbum (Lead) 30X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Salt

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.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858
Uriel, East Troy, WI 53120
shopuriel.com Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Helleborus comp. C AmpulesHelleborus comp. C Ampules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-5119-1Helleborus comp. C10 in 1 BOXLIQUID103
48951-5119-1Helleborus comp. C1 mL in 1 AMPULELIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-5119HELLEBORUS COMP. C LIQUID [URIEL PHARMACY INC.]3Legacy NDC, 2 package rows20241219_8f77df41-58bf-8267-e053-2995a90a90e2.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-511948951-5119-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILVER3M4G523W1GACTIB
LEAD2P299V784PACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
FORMICA RUFA55H0W83JO5ACTIB
BOS TAURUS SPLEEN190Q9MB3U3ACTIB
HELLEBORUS NIGER ROOT608DGJ6815ACTIB
ANTIMONY9IT35J3UV3ACTIB
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT

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
297af0ca-c993-db87-e063-6394a90ae3fb8f77df41-58bf-8267-e053-2995a90a90e22024-12-17WarningsExact identifier
spl id: 297af0ca-c993-db87-e063-6394a90ae3fb
spl set id: 8f77df41-58bf-8267-e053-2995a90a90e2

Reported adverse events (FAERS/openFDA)#

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