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#
Contacts and useful links#
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
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 48951-5130-1 | Helleborus comp. F | 10 in 1 BOX | LIQUID | 10 | 1 | |
| 48951-5130-1 | Helleborus comp. F | 1 mL in 1 AMPULE | LIQUID | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 48951-5130 | HELLEBORUS COMP. F LIQUID [URIEL PHARMACY, INC.] | 1 | 2 package rows | 20230927_de5f6103-a9ef-b06b-e053-2a95a90a8301.zip |
Products#
Every source-derived product name is available through these pages.
- Helleborus comp. F
- WATER
- SODIUM CHLORIDE
- SILICON DIOXIDE
- BOS TAURUS OLFACTORY BULB
- HELLEBORUS NIGER ROOT
- ARNICA MONTANA
- BOS TAURUS NASAL MUCOSA
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 48951-5130 | 48951-5130-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | ACTIB |
| BOS TAURUS OLFACTORY BULB | S46V5TR3J8 | ACTIB |
| HELLEBORUS NIGER ROOT | 608DGJ6815 | ACTIB |
| ARNICA MONTANA | O80TY208ZW | ACTIB |
| BOS TAURUS NASAL MUCOSA | 343455G79K | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| de5f6103-a9f0-b06b-e053-2a95a90a8301 | de5f6103-a9ef-b06b-e053-2a95a90a8301 | 2023-09-26 | Warnings | de5f6103-a9f0-b06b-e053-2a95a90a8301 de5f6103-a9ef-b06b-e053-2a95a90a8301 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
