PECTOL MENTHOL COUGH DROPS Menthol Cough Suppressant/ Oral Anesthetic Menthol Flavor

Menthol Cough Drops by

Drug Labeling and Warnings

Menthol Cough Drops by is a Otc medication manufactured, distributed, or labeled by BOSTON NUTRACEUTICAL PRODUCTION, S.L, Boston Nutraceutical Science SL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MENTHOL 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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PECTOL
MENTHOL COUGH DROPS

Menthol Cough Suppressant/ Oral Anesthetic

Menthol Flavor

Active Ingredient in each drop Purposes

Menthol 5.4 mg

Cough Suppressant

Oral Anesthetic

Front Panel

Purposes

Temporarily relieves ocassional minor irritation and pain due to:

  • sore throat
  • sore mouth

Purposes

Temporarily relieves ocassional minor irritation and pain due to:

  • sore throat
  • sore mouth

Warnings

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

Ask a doctor before use if you have:

  • a severe throat accompanied by difficulty in breathing or that lasts more than 2 days
  • a sore throat accompanied by fever, headache, rash, swelling, nausea and vomiting

Stop use and consult doctor if

  • sore mouth symptons does not improve in 7 days or if,
  • irritation, pain or redness persists or worsens

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

Keep out of the reach of children.

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

Directions

  • Adults and children 12 years and over: dissolve 1 drop slowly in mouth. Repeat every two hours as needed or as directed by a doctor.
  • Children under 12 years do not use

Other information

  • Store in a cool and dry place
  • 11 calories per drop

glucose, syrup, sucrose

Questions or to report an adverse event call:

1 833 5521737

Back Panel

MENTHOL COUGH DROPS 
menthol pastille
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 72628-114
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
Colorwhite (transparent) Scorescore with uneven pieces
ShapeOVALSize25mm
FlavorMENTHOL (and herbal) Imprint Code P
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 72628-114-0130 in 1 BAG; Type 0: Not a Combination Product09/02/202205/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/02/202212/31/2023
Labeler - BOSTON NUTRACEUTICAL PRODUCTION, S.L (468121064)
Registrant - Boston Nutraceutical Science SL (466061824)
Establishment
NameAddressID/FEIBusiness Operations
BOSTON NUTRACEUTICAL PRODUCTION, S.L468121064manufacture(72628-114) , label(72628-114)

Revised: 9/2022
Document Id: e7bb0ce4-9a12-95fa-e053-2995a90ac4eb
Set id: e7bb0ce4-9a11-95fa-e053-2995a90ac4eb
Version: 1
Effective Time: 20220902