FDA.reportPublic FDA data

Helleborus comp. A

Manufacturer
Uriel Pharmacy Inc.
Effective date
2021-03-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:49:16

Label at a glance#

ProductHelleborus comp. A
Active ingredientPHOSPHORUS, ARSENIC TRIOXIDE, LEAD MONOSILICATE, SILVER, FORMICA RUFA, ANTIMONY, HELLEBORUS NIGER ROOT
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: Helleborus (Christmas rose) 3X, Formica (Red wood ant) 6X, Stibium met. (Antimony) 6X, Argentum met. (Silver) 8X, Phosphorus (Yellow phosphorus) 12X, Arsenicum (White arsenic) 17X, Plumbum silicicum (Lead silicate) 20X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Salt, Lactose

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. Contains traces of lactose. 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
www.urielpharmacy.com Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Helleborus comp. AHelleborus comp. A

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-512248951-5122-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHOSPHORUS27YLU75U4WACTIB
ARSENIC TRIOXIDES7V92P67HOACTIM
WATER059QF0KO0RIACT
LEAD MONOSILICATETLE92T7F1JACTIB
SILVER3M4G523W1GACTIB
FORMICA RUFA55H0W83JO5ACTIB
ANTIMONY9IT35J3UV3ACTIB
SODIUM CHLORIDE451W47IQ8XIACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
HELLEBORUS NIGER ROOT608DGJ6815ACTIB

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
150ea693-e719-aad2-e063-6394a90a2c34bd490a1c-9c74-4585-e053-2995a90a47852024-04-01WarningsExact identifier
spl set id: bd490a1c-9c74-4585-e053-2995a90a4785

Reported adverse events (FAERS/openFDA)#

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