MGC HEALTH- cough drops menthol sugar-free lozenge 
YUNNAN BAIYAO GROUP CO., LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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YNBY-MGC Cough Drops Menthol Sugar-Free 25

Active Ingredient(s)

Menthol 5.4 mg

Purpose

Purposes cough suppressant, oral anesthetic

Use

temporary relieves: ■ cough due to cold ■ occasional minor irritation 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.

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 serius condition. ■ sore mouth does not improve in 7 days ■ irritation, pain, or redness persists or worsens.

Keep out of reach of children.

Directions

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

■ children under 5 years: ask a doctor.

Other information

■ 10 calories per drop ■ contains: SOY.

Inactive ingredients


MENTHOL
ACESULFAME POTASSIUM
ASPARTAME
FD&C BLUE NO. 1
FD&C RED NO. 40
POTASSIUM CITRATE
SOY LECITHIN
CITRIC ACID
EUCALYPTUS OIL
SUCRALOSE
ISOMALT
MALTITOL
WATER

Call 2396311907 or visit our website: www.mgc.us

Package Label - Principal Display Panel

Menthol SF 25Menthol Sugar-Free, 25 Drops NDC:61658-113-25

MGC HEALTH 
cough drops menthol sugar-free lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61658-113
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.4 mg
Inactive Ingredients
Ingredient NameStrength
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ISOMALT (UNII: S870P55O2W)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
ASPARTAME (UNII: Z0H242BBR1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
MALTITOL (UNII: D65DG142WK)  
Product Characteristics
ColorblueScorescore with uneven pieces
ShapeOVALSize21mm
FlavorMENTHOLImprint Code B
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61658-113-7070 in 1 BAG; Type 0: Not a Combination Product02/12/2023
2NDC:61658-113-2525 in 1 BAG; Type 0: Not a Combination Product02/12/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/12/2023
Labeler - YUNNAN BAIYAO GROUP CO., LTD (654223122)

Revised: 5/2023
Document Id: fc8608d6-6a4a-d6fc-e053-6394a90a54e8
Set id: f4976961-cdf8-e080-e053-2a95a90a8926
Version: 5
Effective Time: 20230525
 
YUNNAN BAIYAO GROUP CO., LTD