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  5. Label Information: Freegells Cough Drops Menthol Cherry

FDA Label for Freegells Cough Drops Menthol Cherry

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH DROP)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE:
    7. STOP USE ASK DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING,
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS:
    12. PACKAGE LABELING:

Freegells Cough Drops Menthol Cherry Product Label

The following document was submitted to the FDA by the labeler of this product Riclan S.a.. 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.

Drug Facts




Active Ingredient (In Each Drop)



Menthol 5.8 mg


Purpose



Cough suppressant/ Oral anesthetic


Uses



temporarily relieves:

  • cough as may occur with a cold
  • occasional minor irritation and sore throat

Warnings



Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompained or follwed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promtly. These symptoms may be serious.


Ask A Doctor Before Use If You Have:



  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompained by excessive phlegm (mucus)

Stop Use Ask Doctor If



  • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serius condition.
  • sore throat is severe, or irritation, pain o redness lasts or worsens
  • sore mouth does not improve in 7 days

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Directions



 adults and children 5 years and over

 dissolve 1 lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.

 children under 5 years  ask a doctor 


Other Information



  • 11 calories per drop
  • do not use if bags is torn or open
  • Contains: Soy.

Inactive Ingredients:



corn syrup, eucalyptus oil, FD&C red no. 40, natural & artificial flavors,soy lecithin, sucrose and water.


Package Labeling:



Label - Label

Label - Label


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