COUGH DROPS- 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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Cough Drops

Active ingredient 5.4 mg

Cough Suppressant

Oral anesthetic

Front Panel

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

glucose syrup, sucrose

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

Back Panel

COUGH DROPS 
menthol pastille
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.4 mg
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
CORN SYRUP (UNII: 9G5L16BK6N)  
Product Characteristics
Colorwhite (Transparent) Scorescore with uneven pieces
ShapeOVALSize25mm
FlavorMENTHOLImprint Code None
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76162-011-0130 in 1 BAG; Type 0: Not a Combination Product12/14/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/14/2022
Labeler - Topco Associates LLC (006935977)
Registrant - Boston Nutraceutical Science SL (466061824)
Establishment
NameAddressID/FEIBusiness Operations
Boston Nutraceutical Production SL468121064label(76162-011) , pack(76162-011) , manufacture(76162-011)

Revised: 12/2022
Document Id: eff0b0ae-c044-6ea2-e053-2995a90a897d
Set id: eff0b37b-6c08-b687-e053-2a95a90a11a9
Version: 1
Effective Time: 20221216
 
Topco Associates LLC