Cold Relief Menthol
Cold Relief Menthol Syrup
3c325ede-cc55-4e07-a8d1-d1acfb3c885f
HUMAN OTC DRUG LABEL
Sep 9, 2025
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
Product Classification
Product Specifications
INGREDIENTS (7)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
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
Active Ingredient
Pelargonium sidoides 1X
INACTIVE INGREDIENT SECTION
Inactive Ingredient
Ethyl Alcohol
Fructose
Glycerin
Maltodextrin
Menthol
Natural Flavor
Purified Water
DOSAGE & ADMINISTRATION SECTION
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
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
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
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
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
Pregnancy or Breast Feeding
If pregnant or breast-feeding, ask a healthcare professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Keep out of reach of children.
OVERDOSAGE SECTION
Overdose
In case of overdose, seek medical help or contact a Poison Control Center right away.