FDA.reportPublic FDA data

Aurum Stibium Hyoscyamus

Manufacturer
Uriel Pharmacy Inc.
Effective date
2025-09-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:34:56

Label at a glance#

ProductAurum Stibium Hyoscyamus
Active ingredientHYOSCYAMUS NIGER LEAF, ANTIMONY, GOLD
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: Hyoscyamus (Henbane) 4X, Stibium met. (Antimony) 8X, Aurum met. (Metallic gold) 10X

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Sucrose

Prepared using rhythmical processes.

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.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858

Uriel, East Troy WI 53120

shopuriel.com Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aurum Stibium Hyoscyamus PelletsAurum Stibium Hyoscyamus Pellets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-1404-2Aurum Stibium Hyoscyamus1350 in 1 BOTTLE, GLASSPELLET13505

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-140448951-1404-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
HYOSCYAMUS NIGER LEAF32IT7G8BAWACTIB
ANTIMONY9IT35J3UV3ACTIB
GOLD79Y1949PYOACTIB

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
Aurum Stibium HyoscyamusAURUM STIBIUM HYOSCYAMUSUriel Pharmacy Inc.a6697815-e32e-4246-9998-6f1f195888932025-09-02WarningsExact identifier
ndc (package): 48951-1404-2
ndc (product): 48951-1404
ndc11 (package): 48951140402
spl id: 3dd78c5b-a98b-f2c8-e063-6294a90ad62f
spl set id: a6697815-e32e-4246-9998-6f1f19588893

Reported adverse events (FAERS/openFDA)#

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