Helleborus e pl. tota 12

Manufacturer: Uriel Pharmacy Inc.
Effective date: 2025-01-22
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 02:31:31

Label at a glance#

ProductHelleborus e pl. tota 12

Active ingredientHELLEBORUS FOETIDUS 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 (Christmas rose) 12X

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Helleborus e pl. tota 12X Ampules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
48951-5108-1	Helleborus e pl. tota 12	10 in 1 BOX	LIQUID	10		3
48951-5108-1	Helleborus e pl. tota 12	1 mL in 1 AMPULE	LIQUID	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
48951-5108	HELLEBORUS E PL. TOTA 12 LIQUID [URIEL PHARMACY INC.]	3	Current NDC, Legacy NDC, 2 package rows	20250124_6ccb8d0f-6c0b-26ae-e053-2991aa0abeb8.zip

Products#

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

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

Helleborus e pl. tota 12
HELLEBORUS FOETIDUS ROOT
WATER
SODIUM CHLORIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
48951-5108	48951-5108-1

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
HELLEBORUS FOETIDUS ROOT	332Y7EES96	ACTIB
WATER	059QF0KO0R	IACT
SODIUM CHLORIDE	451W47IQ8X	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
Helleborus e pl. tota 12	HELLEBORUS E PL. TOTA 12	Uriel Pharmacy Inc.	6ccb8d0f-6c0b-26ae-e053-2991aa0abeb8	2025-01-22	Warnings	Exact identifier ndc (package): 48951-5108-1 ndc (product): 48951-5108 ndc11 (package): 48951510801 spl id: 2c532194-0bac-f221-e063-6394a90a4ab9 spl set id: 6ccb8d0f-6c0b-26ae-e053-2991aa0abeb8

Reported adverse events (FAERS/openFDA)#

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