COUGH DROPS- menthol tablet, orally disintegrating 
Xinsanyang Pharmaceutical (Xiamen) Co., Ltd.

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Cough Drops

Cough Drops

Menthol

cough suppressant, oral anesthetic

temporarily relieves: cough due to cold, occasional minor irritation or sore throat

Sore throat warning: lf sore throat is severe, persists for more than 2 days, isaccompanied or follow headache, rash, swelling, nausea, or vomiting, consult a doctorprompfly. These 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 1 week, tends to recur,
or is accompained by fever, rash, or persistent headache. These could be signs of a
serious condition. sore mouth does not improve in 7 days

irritation, pain, or redness persists or worsens.

adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeatevery 2 hours as needed.

children under 5 years: ask a doctor.

Stop use and ask a doctor if: 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
serious condition. sore mouth does not improve in 7 days irritation, pain, or redness
persists or worsens.

Keep out of reach of children.

adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeatevery 2 hours as needed.

children under 5 years: ask a doctor.

Dry, avoid sunlight

EUCALYPTUS OIL
FD&C BLUE NO. 1
FD&C RED NO. 40
POTASSIUM CITRATE
SOY LECITHIN
SUCRALOSE
SUCROSE
GLUCOSE SYRUP
CITRIC ACID
Water

label0

COUGH DROPS 
menthol tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80404-501
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.4 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CORN SYRUP (UNII: 9G5L16BK6N)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorblueScorescore with uneven pieces
ShapeOVALSize20mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80404-501-0125 in 1 BAG; Type 0: Not a Combination Product06/29/2023
2NDC:80404-501-0230 in 1 BAG; Type 0: Not a Combination Product06/29/2023
3NDC:80404-501-0370 in 1 BAG; Type 0: Not a Combination Product06/29/2023
4NDC:80404-501-0480 in 1 BAG; Type 0: Not a Combination Product06/29/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/29/2023
Labeler - Xinsanyang Pharmaceutical (Xiamen) Co., Ltd. (546457554)
Establishment
NameAddressID/FEIBusiness Operations
Xinsanyang Pharmaceutical (Xiamen) Co., Ltd.546457554manufacture(80404-501)

Revised: 10/2023
Document Id: 086d83fb-1341-42f9-e063-6294a90a900e
Set id: ff3fa2fa-6741-fa43-e053-6294a90a5d5b
Version: 10
Effective Time: 20231023
 
Xinsanyang Pharmaceutical (Xiamen) Co., Ltd.