FDA.reportPublic FDA data

Helleborus Berberis Special Order

Manufacturer
Uriel Pharmacy Inc.
Effective date
2018-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:10:13

Label at a glance#

ProductHelleborus Berberis Special Order
Active ingredientARISTOLOCHIA CLEMATITIS WHOLE, HELLEBORUS FOETIDUS ROOT, POTASSIUM ALUM, BERBERIS VULGARIS ROOT BARK
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

Dissolve pellets under the tongue 3-4
times daily. Ages 12 and older: 10 pellets.
Ages 2-11: 5 pellets. Under age 2: Consult
a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Aristolochia ex herba
3X, Berberis e fruct. 3X, Helleborus e pl.
tota 3X, Alumen 4X

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Organic sucrose

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 sugar. Diabetics and persons intolerant of sucrose (sugar): Consult a doctor before use. 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. Do not use if safety seal is broken or missing.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HelleborusBerberisSOPelletsHelleborusBerberisSOPellets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-5036-2Helleborus Berberis Special Order1350 in 1 BOTTLE, GLASSPELLET13501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-5036HELLEBORUS BERBERIS SPECIAL ORDER PELLET [URIEL PHARMACY INC.]1Legacy NDC, 1 package rows20180605_6dd63c1f-e59e-e73f-e053-2a91aa0af677.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-503648951-5036-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARISTOLOCHIA CLEMATITIS WHOLET47L342B3CACTIB
HELLEBORUS FOETIDUS ROOT332Y7EES96ACTIB
POTASSIUM ALUM1L24V9R23SACTIB
SUCROSEC151H8M554IACT
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB

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
6dd63c1f-e59f-e73f-e053-2a91aa0af6776dd63c1f-e59e-e73f-e053-2a91aa0af6772018-06-04WarningsExact identifier
spl id: 6dd63c1f-e59f-e73f-e053-2a91aa0af677
spl set id: 6dd63c1f-e59e-e73f-e053-2a91aa0af677