Helleborus comp. F

Manufacturer
Uriel Pharmacy, Inc. | Uriel Pharmacy, Inc
Effective date
2023-09-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:22:21

Label at a glance#

ProductHelleborus comp. F
Active ingredientSILICON DIOXIDE, BOS TAURUS OLFACTORY BULB, HELLEBORUS NIGER ROOT, ARNICA MONTANA, BOS TAURUS NASAL MUCOSA
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 Ingredients: Bulbus olfactorius (Bovine olfactory bulb) 8X, Arnica 12X, Helleborus (Christmas rose) 12X, Jaspis (Jasper) 12X, Tunica mucosa nasi (Bovine nasal mucosa) 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.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858
Uriel, East Troy, WI 53120
shopuriel.com Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Helleborus comp. FHelleborus comp. F

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-5130-1Helleborus comp. F10 in 1 BOXLIQUID101
48951-5130-1Helleborus comp. F1 mL in 1 AMPULELIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-5130HELLEBORUS COMP. F LIQUID [URIEL PHARMACY, INC.]12 package rows20230927_de5f6103-a9ef-b06b-e053-2a95a90a8301.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-513048951-5130-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
de5f6103-a9f0-b06b-e053-2a95a90a8301de5f6103-a9ef-b06b-e053-2a95a90a83012023-09-26WarningsExact identifier
spl id: de5f6103-a9f0-b06b-e053-2a95a90a8301
spl set id: de5f6103-a9ef-b06b-e053-2a95a90a8301

Reported adverse events (FAERS/openFDA)#

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