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

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

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

FREEGELLS COUGH DROPS MENTHOL CHERRY
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71165-011
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.8 mg

Ingredient Name	Strength
Inactive Ingredients
CORN SYRUP (UNII: 9G5L16BK6N)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	20mm
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71165-011-00	30 in 1 BAG; Type 0: Not a Combination Product	10/01/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	10/01/2022

Labeler - Riclan S.A. (911989788)

Freegells Cough Drops Menthol Cherry