NATURAL HERBAL COUGH DROPS- menthol pastille 
BOSTON NUTRACEUTICAL PRODUCTION, S.L

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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Natural Herbal Cough Drops
Cough Suppressant
Oral Anesthetic

Active Ingredient in each drop Purposes

Menthol 4.8 mg

Cough Suppressant

Oral Anesthetic

Purposes

Temporarily relieves :

Purposes

Temporarily relieves :

Warnings

Sore throat warning: is sore throat is severe, persist for more than 2 days, is accompanied or followed by fever headache, rash, swelling, nausea and vomiting maybe serious consult a doctor promptly. If sore mouth symptons do not improve in 7 days, see your dentist or doctor promptly. These symptons may be serious

Ask a doctor before use if you have

Stop use and consult 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

Other information

corn syrup, sucrose, caramel color, elderflower, honehound, hyssop, lemon balm, liden fiwer, malow, peppermint, sage, thyme, wild thyme, natural flavours

Back Label

Questions or to report an adverse event call:

1 617-848-4560

Monday to Friday: 9:00 am to 4:00 pm ET

Label

Label

NATURAL HERBAL COUGH DROPS 
menthol pastille
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72628-107
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.8 mg
Inactive Ingredients
Ingredient NameStrength
LEMON BALM OIL (UNII: MJ76269K9S)  
PEPPERMINT (UNII: V95R5KMY2B)  
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
SAGE (UNII: 065C5D077J)  
THYME (UNII: CW657OBU4N)  
WILD THYME (UNII: KXK6I80R8W)  
MALVA SYLVESTRIS LEAF (UNII: 17H39B00T5)  
HYSSOPUS OFFICINALIS FLOWERING TOP (UNII: X7HKN4FOJI)  
CARAMEL (UNII: T9D99G2B1R)  
HOREHOUND (UNII: K08036XEJV)  
SUCROSE (UNII: C151H8M554)  
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
CORN SYRUP (UNII: 9G5L16BK6N)  
Product Characteristics
Colorbrown (dark) Scorescore with uneven pieces
ShapeOVALSize25mm
FlavorMENTHOL (and herbal) Imprint Code P
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72628-107-0150 in 1 BAG; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/01/2020
Labeler - BOSTON NUTRACEUTICAL PRODUCTION, S.L (468121064)
Registrant - Boston Nutraceutical Science SL (466061824)
Establishment
NameAddressID/FEIBusiness Operations
BOSTON NUTRACEUTICAL PRODUCTION, S.L468121064manufacture(72628-107) , label(72628-107)

Revised: 6/2020
Document Id: a706ed57-ef38-6e5d-e053-2995a90a59f7
Set id: a706ee9c-9ed0-d3f1-e053-2a95a90a26d6
Version: 1
Effective Time: 20200601
 
BOSTON NUTRACEUTICAL PRODUCTION, S.L