COUGH DROPS- menthol granule

Cough Drops by

Drug Labeling and Warnings

Cough Drops by is a Otc medication manufactured, distributed, or labeled by Xiamen Kang Zhongyuan Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 0.18%

Purpose

cough suppressant,oral anesthetic

Use

Cough due to cold

Occasional minor imtation or sore throat

Warnings

Sore throat warning: If sore throat is severe,persists for more than 2 days,is accompanied or follow headache,rash,swelling,nausea,or vomiting,consult a doctor promptly. These may be serious.

Do not use

persistent or chronic cough such as occurs cough accompanied by excessive phlegm with smoking, asthma, or emphysema (mucus).

Stop Use

Stop use and ask a doctor if:
1,cough persists for more than 1 week,tends to recur,
or is accompained by fever,rash,or persistent headache.These could be signs of a serius condition.

2, sore mouth does not improve in 7 days

3,irritation, pain, or redness persists or worsens.

Keep Oot Of Reach Of Children

Please do not place this product in an area accessible to unconscious people.

In case of accidental ingestion, seek medical help right away.

Directions

adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.muchildren under 5 years:ask a doctor.

Other information

1,10calories per drop

2,contains ：soy

Inactive ingredients

citric acid,eucalyptus oil,FD&C blue 1,FD&C red 40, flavors, glucose syrup, potassium citrate,soy lecithin,sucralose,sucrose,water.

Questions

Call2396311907 or visit our website :www.mgc.us

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COUGH DROPS 
menthol granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83698-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.18 g  in 100

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83698-001-01	25 in 1 BOTTLE; Type 0: Not a Combination Product	09/13/2023
2	NDC: 83698-001-02	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/13/2023
3	NDC: 83698-001-03	70 in 1 BOTTLE; Type 0: Not a Combination Product	09/13/2023
4	NDC: 83698-001-04	80 in 1 BOTTLE; Type 0: Not a Combination Product	09/13/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/13/2023

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

Establishment
Name	Address	ID/FEI	Business Operations
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.		411759931	label(83698-001) , manufacture(83698-001)