FDA.reportPublic FDA data

Helleborus niger 3

Manufacturer
Uriel Pharmacy Inc.
Effective date
2018-05-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:57:29

Label at a glance#

ProductHelleborus niger 3
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) 3X

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

HelleborusNiger3AmpulesHelleborusNiger3Ampules

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
48951-510948951-5109-1

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
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT

Source Document#

Source XML · Source PDF

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
c69efe57-5cd8-3a36-e053-2995a90ada0d6ce281a8-d59e-3433-e053-2991aa0a8d962021-07-08WarningsExact identifier
spl set id: 6ce281a8-d59e-3433-e053-2991aa0a8d96

Reported adverse events (FAERS/openFDA)#

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