Helleborus niger 12X

Manufacturer: Uriel Pharmacy Inc.
Effective date: 2024-09-23
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:28:02

Label at a glance#

ProductHelleborus niger 12X

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 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 Ingredient: Helleborus e pl. tota (Christmas rose) 12X

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
Uriel, East Troy, WI 53120
shopuriel.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Helleborus niger 12X Liquid

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
48951-5139-3	2026-01-29	C162847	48780-1	49896155-a353-586f-e063-e6dba90add90	Helleborus niger 12X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
48951-5139-3	Helleborus niger 12X	60 mL in 1 BOTTLE, DROPPER	LIQUID	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
48951-5139	HELLEBORUS NIGER 12X LIQUID [URIEL PHARMACY INC.]	1	1 package rows	20240926_22cead2a-578a-c4db-e063-6394a90a73c2.zip

Products#

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

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

Helleborus niger 12X
HELLEBORUS NIGER ROOT
ALCOHOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
48951-5139	48951-5139-3

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
HELLEBORUS NIGER ROOT	608DGJ6815	ACTIB
ALCOHOL	3K9958V90M	IACT
WATER	059QF0KO0R	IACT

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
22ce836d-cad8-3064-e063-6394a90adb45			22cead2a-578a-c4db-e063-6394a90a73c2	2024-09-23	Warnings	Exact identifier spl id: 22ce836d-cad8-3064-e063-6394a90adb45 spl set id: 22cead2a-578a-c4db-e063-6394a90a73c2

Reported adverse events (FAERS/openFDA)#

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