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Cold Relief Zero Sugar Grape

Cold Relief Zero Sugar Grape Syrup

Approved
Approval ID

9160182c-a1c1-49db-8a3d-01a30f7cbd78

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 16, 2025

Manufacturers
FDA

Schwabe North America, Inc

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 Code53499-6794
Product Classification
G
Generic Name
Pelargonium sidoides
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 16, 2025
FDA Product Classification

INGREDIENTS (9)

PELARGONIUM SIDOIDES ROOTActive
Quantity: 1 [hp_X] in 120 mL
Code: H6J53HEX8E
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CABBAGEInactive
Code: GW0W1Y9I97
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/16/2025

![LH15794.C02-Umcka-Cold-Relief-ZS-Grape- Syrup-4oz.jpg](/dailymed/image.cfm?name=LH15794.C02-Umcka-Cold-Relief-ZS- Grape-Syrup-4oz.jpg&id=897993)

![LHBN15794.C03-Umcka-Cold-Relief-ZS-Grape- Syrup-4oz.jpg](/dailymed/image.cfm?name=LHBN15794.C03-Umcka-Cold-Relief-ZS- Grape-Syrup-4oz.jpg&id=897993)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/16/2025

Indications & Usage

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/16/2025

Active Ingredient

Pelargonium sidoides 1X

Inactive Ingredients

Citric Acid

Ethyl Alcohol

Glycerin

Maltodextrin

Natural Flavor

Potassium Sorbate

Purified Water

Red Cabbage Juice Color

Sorbitol

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/16/2025

Dosage and Administration

Directions

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

Shake well before each use.

Use only with enclosed dosage cup.

Adults & children 13 years of age and older: Take 1 ½ teaspoon (tsp) (7.5 mL) three times daily.

Children 6-12 years of age: Take 1 teaspoon (5mL) three times daily.

Children under 6 years of age: Consult a doctor.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/16/2025

Purpose

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat.

WARNINGS SECTION

LOINC: 34071-1Updated: 9/16/2025

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.

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.

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, or cough lasts more than 7 days or occurs with rash or persistent headache.

These could be signs of a serious condition.

Pregnancy or Breast Feeding

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

Keep out of reach of children

Keep out of reach of children.

Overdose

In case of overdose, seeek medical help or contact a Poison Control Center right away.

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Cold Relief Zero Sugar Grape - FDA Drug Approval Details