FDA.reportPublic FDA data

Helleborus niger 12

Manufacturer
Uriel Pharmacy Inc.
Effective date
2021-07-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:41:22

Label at a glance#

ProductHelleborus niger 12
Active ingredientHELLEBORUS FOETIDUS ROOT
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 Ingredient: Helleborus niger (Christmas rose) 12X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Salt

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Helleborus niger 12XHelleborus niger 12X

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-511448951-5114-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
HELLEBORUS FOETIDUS ROOT332Y7EES96ACTIB
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
0f15c2c9-1004-bb29-e063-6294a90a452d82427dca-8f63-8950-e053-2a91aa0a5f492024-01-16WarningsExact identifier
spl set id: 82427dca-8f63-8950-e053-2a91aa0a5f49

Reported adverse events (FAERS/openFDA)#

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