MedPath

SOVEREIGN SILVER MULTI-SYMPTOM SORE THROAT

Approved
Approval ID

b5ef5d51-61d6-4a46-b68d-95150bb06bbb

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 22, 2025

Manufacturers
FDA

Natural Immunogenics Corp.dba SOVEREIGN NATURALS

DUNS: 048744085

Products 1

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

ARGENTUM NITRICUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code52166-052
Product Classification
G
Generic Name
ARGENTUM NITRICUM
Product Specifications
Route of AdministrationORAL
Effective DateMay 22, 2025
FDA Product Classification

INGREDIENTS (6)

ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SILVERInactive
Code: 3M4G523W1G
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SILVER NITRATEActive
Quantity: 10 [hp_X] in 1 mL
Code: 95IT3W8JZE
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/25/2024

Product label

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/25/2024

Uses

For the temporary relief of minor sore throat.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/25/2024

Active Ingredient Purpose

Argentum Nitricum 10xHPUS For the temporary relief of minor sore throat

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/25/2024

WARNINGS SECTION

LOINC: 34071-1Updated: 6/25/2024

Warnings

*Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. • Do not use for more than 7 consecutive days.

*When using this productdo not exceed recommended dosage.

*Stop use and ask a physician if: Sore throat symptoms do not improve in 7 days. Irritation, pain or redness persists or worsens.Swelling, rash or fever develops.

*If pregnant or breast-feeding: Ask a physician before use.

*Keep out of reach of children.

*Do not use if seal is broken.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/25/2024

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/25/2024

Directions

*Adults and children 13 and older: Apply 3 sprays directly to the throat, then swallow. Wait for 5 minutes and repeat the process. If symptoms persist, wait 10 minutes after the second dose and reapply as needed until bedtime. *Children 12 and under: Consult with a physician.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/25/2024

Questions or comments?

888-328-8840

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/25/2024

Inactive ingredients

Alcohol (Organic) 0.6%, Citric acid, Glycerin, Silver, Sodium Citrate.

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