FREEGELLS COUGH DROPS MENTHOL 80CT- menthol lozenge

Freegells Cough Drops Menthol 80ct by

Drug Labeling and Warnings

Freegells Cough Drops Menthol 80ct by is a Otc medication manufactured, distributed, or labeled by RL Albert & Son Inc.. 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

Sore throat warning:if sore throat is severe, persists for more than 2 days, is accompanied or followed 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 promptly. 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 accompanied by excessive phlegm (mucus)

Stop use and ask a 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 serious condition.
• sore throat is severe, or irritation, pain or 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

Product label

INGREDIENTS AND APPEARANCE

FREEGELLS COUGH DROPS MENTHOL 80CT 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83002-042
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	5.4 mg

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
CORN SYRUP (UNII: 9G5L16BK6N)
EUCALYPTOL (UNII: RV6J6604TK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ACACIA (UNII: 5C5403N26O)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83002-042-01	6 in 1 CARTON	03/15/2024
1		80 in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/15/2024

Labeler - RL Albert & Son Inc. (005900899)