MedPath

Aurum Stibium Hyoscyamus

Aurum Stibium Hyoscyamus

Approved
Approval ID

29ca80e6-3797-4ca2-a9cc-ea384b38ba5b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 2, 2025

Manufacturers
FDA

URIEL PHARMACY INC.

DUNS: 043471163

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Aurum Stibium Hyoscyamus

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code48951-1403
Product Classification
G
Generic Name
Aurum Stibium Hyoscyamus
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 2, 2025
FDA Product Classification

INGREDIENTS (5)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
HYOSCYAMUS NIGER LEAFActive
Quantity: 4 [hp_X] in 1 1
Code: 32IT7G8BAW
Classification: ACTIB
ANTIMONYActive
Quantity: 8 [hp_X] in 1 1
Code: 9IT35J3UV3
Classification: ACTIB
GOLDActive
Quantity: 10 [hp_X] in 1 1
Code: 79Y1949PYO
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/2/2025

Aurum Stibium Hyoscyamus Liquid

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/11/2013

Directions: FOR ORAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/11/2013

Take 3-4 times daily. Ages 12 and older: 10 drops. Ages 2-11: 5 drops. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/11/2013

Active Ingredients: Hyoscyamus (Henbane) 4X, Stibium metallicum (Antimony) 8X, Aurum metallicum (Metallic gold) 10X

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/11/2013

Inactive Ingredients: Distilled water, 20% Organic cane alcohol

Prepared using rhythmical processes.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/11/2013

Use: Temporary relief of headache.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 12/11/2013

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

LOINC: 34071-1Updated: 12/11/2013

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. Do not use if safety seal is broken or missing.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 12/11/2013

Questions? Call 866.642.2858
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