MENTHOL FLAVOR COUGH DROP lozenge

Menthol Flavor Cough Drop by

Drug Labeling and Warnings

Menthol Flavor Cough Drop by is a Otc medication manufactured, distributed, or labeled by Xiamen Kang Zhongyuan Biotechnology Co., Ltd., Medical Group Care, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredeint (in each Lozenge)

Menthol 5.4 mg

PURPOSE

Purpose

Cough suppressant/Oral anesthetic

INDICATIONS & USAGE

Uses

temporarily relieves:

• cough due to a cold
• occasional minor irritation, pain, sore mouth, and sore throat

WARNINGS

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. 

ASK DOCTOR

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)

WHEN USING

When using this product do not exceed recommended dosage

STOP USE

Stop use and ask doctor if

• cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
• sore mouth does not improve in 7 days
• irritation, pain or redness persists or worsens

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

• adults and children 2 years and over: dissolve lozenge slowly in mouth. Repeat every 2 hours as needed or as directed by a doctor.
• children under 2 years: ask a doctor

OTHER SAFETY INFORMATION

Other information

• Store at room termperature
• keep away from excessive heat or sunlight
• do not use if primary bag seal has been torn or broken
• CONTAINS: SOY

INACTIVE INGREDIENT

Inactive ingredients

citric acid, corn syrup, eucalyptus oil, FD&C blue 1, FD&C red 40, menthol flavor, potassium citrate, soy lecithin, sucralose, sucrose, water

QUESTIONS

Questions or comments?

Call +8009352362

You may also report concerns to this phone number

Monday-Friday, 9AM - 5PM Eastern Time

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MENTHOL FLAVOR COUGH DROP 
menthol flavor cough drop lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83698-581
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CORN SYRUP (UNII: 9G5L16BK6N)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POTASSIUM CITRATE (UNII: EE90ONI6FF)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	21mm
Flavor	MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83698-581-30	30 in 1 BAG; Type 0: Not a Combination Product	08/22/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	08/22/2024

Labeler - Xiamen Kang Zhongyuan Biotechnology Co., Ltd. (411759931)

Registrant - Medical Group Care, LLC (085137089)