MENTHOL COUGH DROPS- menthol pastille 
Boston Nutraceutical Production SL

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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Menthol Cough Drops
Sugar Free
Sweetened with Stevia Extract
36 drops

Active Ingredient in each drop Purposes

Menthol 5.8 mg

Cough Suppressant

Oral anesthetic

Front label

Purposes

Cough suppressant/

Oral anesthetic

Uses Temporarily relieves:

Warnings

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swealing, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms 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

persistent or chronic cough such as occurs with smoking, asthma, or emphysema

cough accompanied by excessvie phlegm (mucus)

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

Isomalt, stevia, water

Back

Questions or comments call: 617-848-4560

Front

MENTHOL COUGH DROPS 
menthol pastille
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72628-105
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.8 mg
Inactive Ingredients
Ingredient NameStrength
ISOMALT (UNII: S870P55O2W)  
WATER (UNII: 059QF0KO0R)  
STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)  
Product Characteristics
Colorblue (Light blue) Scorescore with uneven pieces
ShapeOVALSize17mm
FlavorMENTHOLImprint Code None
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72628-105-0136 in 1 BAG; Type 0: Not a Combination Product03/26/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/26/2019
Labeler - Boston Nutraceutical Production SL (468121064)
Registrant - Boston Nutraceutical Science SL (466061824)
Establishment
NameAddressID/FEIBusiness Operations
Boston Nutraceutical Production SL468121064manufacture(72628-105) , label(72628-105) , pack(72628-105)

Revised: 1/2021
Document Id: b8f51795-2016-f2da-e053-2a95a90af7de
Set id: 857363b6-e025-e074-e053-2a91aa0a4379
Version: 2
Effective Time: 20210115
 
Boston Nutraceutical Production SL