Helleborus niger 3

Manufacturer: Uriel Pharmacy Inc.
Effective date: 2024-01-19
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 02:25:45

Label at a glance#

ProductHelleborus niger 3

Active ingredientHELLEBORUS NIGER ROOT

Label structure9 sections

Contacts and useful links#

PhoneLabel contact866.642.2858

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

"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 niger 3X Ampules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
48951-5123-1	Helleborus niger 3	1 mL in 1 AMPULE	LIQUID	1		2
48951-5123-1	Helleborus niger 3	8 in 1 BOX	LIQUID	8		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
48951-5123	HELLEBORUS NIGER 3 LIQUID [URIEL PHARMACY INC.]	2	Legacy NDC, 2 package rows	20240120_c69f7fe0-592f-b50c-e053-2995a90a3ca6.zip

Products#

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

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

Helleborus niger 3
WATER
SODIUM CHLORIDE
HELLEBORUS NIGER ROOT

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
48951-5123	48951-5123-1

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
Name	UNII	Kind
WATER	059QF0KO0R	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
HELLEBORUS NIGER ROOT	608DGJ6815	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0f534cd9-5033-0d0c-e063-6394a90ac11c			c69f7fe0-592f-b50c-e053-2995a90a3ca6	2024-01-19	Warnings	Exact identifier spl id: 0f534cd9-5033-0d0c-e063-6394a90ac11c spl set id: c69f7fe0-592f-b50c-e053-2995a90a3ca6

Reported adverse events (FAERS/openFDA)#

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