FREEGELLS COUGH DROPS MENTHOL HONEY LEMON- menthol lozenge 
Riclan S.A.

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Freegells Cough Drops Menthol Honey Lemon

Drug Facts

Active ingredient (in each drop)

Menthol 7.5 mg

Purpose

Cough suppressant/ Oral anesthetic

Uses

temporarily relieves:

Warnings

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. Sore throat warning:

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.

Keep out of reach of children.

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

Inactive ingredients:

beta carotene, corn syrup, eucalyptus oil, honey, natural & artificial flavors, soy lecithin, sucrose and water.

Package Labeling:71165-013-00

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Package Labeling:71165-013-01

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FREEGELLS COUGH DROPS MENTHOL HONEY LEMON 
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71165-013
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.5 mg
Inactive Ingredients
Ingredient NameStrength
BETA CAROTENE (UNII: 01YAE03M7J)  
CORN SYRUP (UNII: 9G5L16BK6N)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
HONEY (UNII: Y9H1V576FH)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColoryellowScoreno score
ShapeOVALSize20mm
FlavorHONEY, LEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71165-013-0030 in 1 BAG; Type 0: Not a Combination Product10/01/2022
2NDC:71165-013-01200 in 1 BAG; Type 0: Not a Combination Product10/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/01/2022
Labeler - Riclan S.A. (911989788)

Revised: 10/2023
Document Id: 08a1dbae-5c73-f0b8-e063-6294a90a44be
Set id: f6271e85-9ca2-41d3-9bff-a13670ac5b80
Version: 2
Effective Time: 20231026
 
Riclan S.A.