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ViraClear EPs 7630 Original

V CLEAR EPs 7630 Original

Approved
Approval ID

d2292488-b45b-49e6-a7d0-3742536e98e8

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 17, 2025

Manufacturers
FDA

Schwabe North America

DUNS: 831153908

Products 1

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

Pelargonium sidoides

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59800-8001
Product Classification
G
Generic Name
Pelargonium sidoides
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2025
FDA Product Classification

INGREDIENTS (5)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PELARGONIUM SIDOIDES ROOTActive
Quantity: 1 [hp_X] in 30 mL
Code: H6J53HEX8E
Classification: ACTIB
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/17/2025

![LBZ780011.A03-V-Clear- EPS-7630-Liquid-1-oz-(G+D).jpg](/dailymed/image.cfm?name=LBZ780011.A03-V-Clear- EPS-7630-Liquid-1-oz-%28G%2BD%29.jpg&id=898263)

![LZ780011.A03-V-Clear- EPS-7630-Liquid-1-oz.jpg](/dailymed/image.cfm?name=LZ780011.A03-V-Clear- EPS-7630-Liquid-1-oz.jpg&id=898263)

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/17/2025

Active Ingredient

Pelargonium sidoides 1X

Inactive Ingredients

Ethyl Alcohol

Glycerin

Maltodextrin

Purified Water

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/17/2025

Dosage & Administration

Directions

For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

Use only with enclosed dropper.

Adults & children 13 years of age and older: Take 1.5 mL three times daily by mouth.

Children under 12 years of age: Consult a physician before use.

Indications & Usage:

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations:

chest congestion, cough, hoarseness, sore throat, nasal congestion.

Purpose

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations:

chest congestion, cough, hoarseness, sore throat, nasal congestion.

WARNINGS SECTION

LOINC: 34071-1Updated: 9/17/2025

Warnings

Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 9/17/2025

Ask Doctor

Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plants of the Geraniaceae family.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/17/2025

Stop Use

Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 9/17/2025

Pregnancy or Breast Feeding

If pregnant or breast-feeding, ask a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/17/2025

Keep out of reach of children

Keep out of reach of children.

OVERDOSAGE SECTION

LOINC: 34088-5Updated: 9/17/2025

Overdose

In case of overdose, seek medical help or contact a Posion Control Center right away.

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ViraClear EPs 7630 Original - FDA Drug Approval Details