COLD RELIEF MENTHOL- pelargonium sidoides syrup

Cold Relief Menthol by

Drug Labeling and Warnings

Cold Relief Menthol by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe North America, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Pelargonium sidoides 1X

Inactive Ingredient

Ethyl Alcohol

Fructose

Glycerin

Maltodextrin

Menthol

Natural Flavor

Purified Water

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 teaspoon (tsp) (7.5 mL) 3 times daily.

Children under 12 years of age and under: 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, nasal congestion, cough, hoarseness, sore throat.

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

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 physician 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, seek medical help or contact a Poison Control Center right away. 

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

COLD RELIEF MENTHOL 
pelargonium sidoides syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-6272
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E)	PELARGONIUM SIDOIDES ROOT	1 [hp_X]  in 120 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
FRUCTOSE (UNII: 6YSS42VSEV)
GLYCERIN (UNII: PDC6A3C0OX)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	MENTHOL (NATURAL MENTHOL FLAVOR) , SPEARMINT (NATURAL SPEARMINT FLAVOR)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-6272-5	1 in 1 CARTON	01/17/2025
1		120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 53499-6272-9	1 in 1 CARTON	01/17/2025
2		240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/17/2025

Labeler - Schwabe North America, Inc (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc		831153908	manufacture(53499-6272)