Active Ingredient
Pelargonium sidoides 1X
Cold Relief Menthol Syrup
FDA Label NDC 53499-6272
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Schwabe North America, Inc for the product Cold Relief Menthol (NDC 53499-6272). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, inactive ingredient, dosage & administration, indications & usage, purpose, warnings, ask doctor, stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
* Please review the disclaimer below.
