FREEGELLS COUGH DROPS MENTHOL EUCALYPTUS- menthol lozenge

Freegells Cough Drops Menthol Eucalyptus by

Drug Labeling and Warnings

Freegells Cough Drops Menthol Eucalyptus by is a Otc medication manufactured, distributed, or labeled by Riclan S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each drop)

Menthol 5.4 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 blue no. 1, FD&C red no. 40, gum arabic, maltodextrin, natural flavor, soy lecithin, sucrose and water.

Package Labeling:71165-012-00

Package Labeling:71165-012-01

INGREDIENTS AND APPEARANCE

FREEGELLS COUGH DROPS MENTHOL EUCALYPTUS 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71165-012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5.4 mg

Inactive Ingredients
Ingredient Name	Strength
CORN SYRUP (UNII: 9G5L16BK6N)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	20mm
Flavor	MENTHOL (EUCALYPTUS)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71165-012-00	30 in 1 BAG; Type 0: Not a Combination Product	10/01/2022
2	NDC: 71165-012-01	80 in 1 BAG; Type 0: Not a Combination Product	10/01/2022

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

Labeler - Riclan S.A. (911989788)