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Cold Relief Menthol

Cold Relief Menthol Syrup

Approved
Approval ID

3c325ede-cc55-4e07-a8d1-d1acfb3c885f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 9, 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 Code53499-6272
Product Classification
G
Generic Name
Pelargonium sidoides
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2025
FDA Product Classification

INGREDIENTS (7)

ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FRUCTOSEInactive
Code: 6YSS42VSEV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
PELARGONIUM SIDOIDES ROOTActive
Quantity: 1 [hp_X] in 120 mL
Code: H6J53HEX8E
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

LH15792_A02_Umcka_ColdRelief_Mint_8oz_LBL_FNL.jpg

LHBN15792_A02_Umcka_ColdRelief_Mint_8oz_CTN_FNL.jpg

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/17/2025

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: 1/17/2025

Active Ingredient

Pelargonium sidoides 1X

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/17/2025

Inactive Ingredient

Ethyl Alcohol

Fructose

Glycerin

Maltodextrin

Menthol

Natural Flavor

Purified Water

DOSAGE & ADMINISTRATION SECTION

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

Dosage & Administration

Directions

For best results, use at the 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 teaspoons (tsp) (7.5 mL) three times daily.

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/17/2025

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: 9/9/2025

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: 9/9/2025

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: 9/9/2025

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, or 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: 1/17/2025

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: 1/17/2025

Keep out of reach of children.

Keep out of reach of children.

OVERDOSAGE SECTION

LOINC: 34088-5Updated: 1/17/2025

Overdose

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

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Cold Relief Menthol - FDA Drug Approval Details