FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPS- menthol suspension/ drops

FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPS by

Drug Labeling and Warnings

FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPS by is a Otc medication manufactured, distributed, or labeled by R.L. ALBERT & SON, INC, Riclan S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

 Menthol 2.7mg

Purpose

Cough Suppressant / Oral anesthetic

Use

• Cough as may occur with a cold
• Occasional minor irritation and sore throat

Warning

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 accompanined by excessive phlegm (mucus)

stop use and 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 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 2 lozenges (one at a time) 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 bag is torn or open 
• Contains : Soy

Inactive ingredients

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

Product label

INGREDIENTS AND APPEARANCE

FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPS 
menthol suspension/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83002-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.7 mg

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	pink	Score
Shape	OVAL	Size	15mm
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83002-001-01	9 in 1 CARTON	11/15/2022
1		30 in 1 BAG
1		1 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 final	part341	11/15/2022

Labeler - R.L. ALBERT & SON, INC (005900899)

Establishment
Name	Address	ID/FEI	Business Operations
Riclan S.A.		911989788	manufacture(83002-001)