HONEY LEMON MENTHOL COUGH DROPS- honey lemon menthol pastille 
Topco Associates LLC

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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Honey Lemon Menthol Cough Drops

Active ingredient 7.5 mg

Cough Suppressant

Oral anesthetic

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Uses temporarily relieves:

Uses temporarily relieves:

Warnings

Sore throat warning: severe or persistence sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 12 years of age.

Ask a doctor before use if you have

Stop use and consult a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep this and all drugs out of the reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

citric acid, honey, flavors, glucose syrup, sucrose, turmeric

Questions? or to report and adverse event call: 1-800-423-0139

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HONEY LEMON MENTHOL COUGH DROPS 
honey lemon menthol pastille
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-024
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.5 mg
Inactive Ingredients
Ingredient NameStrength
CORN SYRUP (UNII: 9G5L16BK6N)  
SUCROSE (UNII: C151H8M554)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
HONEY (UNII: Y9H1V576FH)  
TURMERIC (UNII: 856YO1Z64F)  
Product Characteristics
ColoryellowScorescore with uneven pieces
ShapeOVALSize25mm
FlavorHONEYImprint Code None
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76162-024-0130 in 1 BAG; Type 0: Not a Combination Product06/08/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/08/2023
Labeler - Topco Associates LLC (006935977)
Registrant - Boston Nutraceutical Science SL (466061824)
Establishment
NameAddressID/FEIBusiness Operations
Boston Nutraceutical Production SL468121064label(76162-024) , pack(76162-024) , manufacture(76162-024)

Revised: 6/2023
Document Id: fdf75b2b-135c-4c4e-e053-6394a90afe66
Set id: f5be283b-524d-26af-e053-2995a90a3972
Version: 2
Effective Time: 20230607
 
Topco Associates LLC