MedPath

Aurum Stibium Hyoscyamus

Aurum Stibium Hyoscyamus

Approved
Approval ID

3dd7da72-ab65-696f-e063-6294a90a3ef1

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.

48951-1405-1

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code48951-1405
Product Classification
G
Generic Name
48951-1405-1
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 2, 2025
FDA Product Classification

INGREDIENTS (5)

ANTIMONYActive
Quantity: 8 [hp_X] in 1 mL
Code: 9IT35J3UV3
Classification: ACTIB
HYOSCYAMUS NIGER LEAFActive
Quantity: 4 [hp_X] in 1 mL
Code: 32IT7G8BAW
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
GOLDActive
Quantity: 10 [hp_X] in 1 mL
Code: 79Y1949PYO
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Aurum Stibium Hyoscyamus Ampules

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/2/2025

Directions: FOR ORAL USE.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/2/2025

Take the contents of one ampule under the
tongue and hold for 30 seconds, then swallow.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/2/2025

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/2/2025

Inactive Ingredients: Water, Salt

Prepared using rhythmical processes.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/2/2025

Use: Temporary relief of headache.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/2/2025

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

LOINC: 34071-1Updated: 9/2/2025

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.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/2/2025

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

Lot:

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