COUGH DROPS- menthol pastille 
United Natural Foods, Inc.

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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Cough Drops

Active Ingredient

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

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Questions or comments: 1-855-423-2630

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COUGH DROPS 
menthol pastille
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83455-206
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.4 mg
Inactive Ingredients
Ingredient NameStrength
CORN SYRUP (UNII: 9G5L16BK6N)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
Coloryellow (Transparent) Scorescore with uneven pieces
ShapeOVALSize25mm
FlavorMENTHOLImprint Code None
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83455-206-0130 in 1 BAG; Type 0: Not a Combination Product05/12/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/12/2023
Labeler - United Natural Foods, Inc. (943556183)
Registrant - Boston Nutraceutical Science SL (466061824)
Establishment
NameAddressID/FEIBusiness Operations
Boston Nutraceutical Production SL468121064manufacture(83455-206) , label(83455-206) , pack(83455-206)

Revised: 5/2023
Document Id: fb7f5ae0-fa8c-a21a-e053-6294a90a9866
Set id: fb7fa728-911d-aaf0-e053-6394a90ace31
Version: 1
Effective Time: 20230512
 
United Natural Foods, Inc.