QUALITY CHOICE- cough drops honey lemon 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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QC-MGC-YNBY Honey Lemon SF Drops 25

Active Ingredient(s)

Menthol 7.6 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

Beta carotene, eucalyptus oil, flavors, isomalt, soy lecithin, sucralose, maltitol, water

Call 800 935 2362 Monday-Friday 9AM-5PM EST

Package Label - Principal Display Panel

QC label25 Drops NDC: 61658-616-25

QUALITY CHOICE 
cough drops honey lemon sugar free lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61658-616
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.6 mg
Inactive Ingredients
Ingredient NameStrength
ISOMALT (UNII: S870P55O2W)  
MALTITOL (UNII: D65DG142WK)  
BETA CAROTENE (UNII: 01YAE03M7J)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColoryellowScorescore with uneven pieces
ShapeOVALSize21mm
FlavorMENTHOLImprint Code B
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61658-616-2525 in 1 BAG; Type 0: Not a Combination Product07/15/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/15/2023
Labeler - YUNNAN BAIYAO GROUP CO., LTD (654223122)
Registrant - Medical Group Care LLC (085137089)

Revised: 7/2023
Document Id: 00dcd6f5-664f-accd-e063-6294a90af6fe
Set id: 00dcd6f5-6650-accd-e063-6294a90af6fe
Version: 1
Effective Time: 20230719
 
YUNNAN BAIYAO GROUP CO., LTD