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  5. Label Information: Cold Relief Menthol

FDA Label for Cold Relief Menthol

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. INACTIVE INGREDIENT
    3. DOSAGE & ADMINISTRATION
    4. INDICATIONS & USAGE
    5. PURPOSE
    6. WARNINGS
    7. ASK DOCTOR
    8. STOP USE
    9. PREGNANCY OR BREAST FEEDING
    10. KEEP OUT OF REACH OF CHILDREN.
    11. OVERDOSE

Cold Relief Menthol Product Label

The following document was submitted to the FDA by the labeler of this product Schwabe North America, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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. 


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