Helleborus comp. A

Manufacturer
Uriel Pharmacy Inc.
Effective date
2025-11-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:35:20

Label at a glance#

ProductHelleborus comp. A
Active ingredientTIN, PHOSPHORUS, ARSENIC TRIOXIDE, LEAD MONOSILICATE, SILVER, FORMICA RUFA, ANTIMONY, HELLEBORUS NIGER ROOT, POTASSIUM PHOSPHATE, MONOBASIC, JUGLANS REGIA LEAF
Label structure9 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Use: Temporary relief of headache.

INDICATIONS & USAGE SECTION

FOR ORAL USE ONLY

DOSAGE & ADMINISTRATION SECTION

Directions: Take the contents of one ampule under
the tongue and hold for 30 seconds, then swallow.
Follow inside instructions to open ampule.

WARNINGS SECTION

Warnings:
NOT FOR INJECTION
Do not use if allergic to any ingredient. Contains traces of lactose. Consult a physician if symptoms worsen. If pregnant or nursing, consult a physician before use.

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Helleborus (Christmas rose) 3X, Formica (Red wood ant) 6X, Kalium phos.(potassium dihydrogenphosphate) 6X,Stibium met. (Antimony) 6X, Juglans reg. e fol. et fruct (walnut) 7X, 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

Prepared using rhythmical processes.

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Helleborus comp. A AmpulesHelleborus comp. A Ampules

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
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63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
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362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
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0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
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684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
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ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-5135-1Helleborus comp. A1 mL in 1 AMPULELIQUID13
48951-5135-1Helleborus comp. A10 in 1 BOXLIQUID103

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-513548951-5135-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
Helleborus comp. AHELLEBORUS COMP. AUriel Pharmacy Inc.150e57ad-3ed7-5cc9-e063-6394a90a25fe2025-11-21WarningsExact identifier
ndc (package): 48951-5135-1
ndc (product): 48951-5135
ndc11 (package): 48951513501
spl id: 4420fb70-8e19-709c-e063-6394a90a1e7a
spl set id: 150e57ad-3ed7-5cc9-e063-6394a90a25fe

Reported adverse events (FAERS/openFDA)#

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