Label: MENTHOL VAPOR COUGH DROPS- menthol pastille

  • NDC Code(s): 72628-108-01
  • Packager: BOSTON NUTRACEUTICAL PRODUCTION, S.L
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated February 6, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient in each drop Purposes

    Menthol 20 mg

    Severe

    Menthol Caugh Suppressant

    Oral Anesthetic

  • PURPOSE

    Purposes

    Temporarily relieves ocassional minor irritation and pain due to:

    • sore throat
    • sore mouth
  • INDICATIONS & USAGE

    Purposes

    Temporarily relieves ocassional minor irritation and pain due to:

    • sore throat
    • sore mouth

  • WARNINGS

    Warnings

    Sore throat warning: severe or persistent 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 of old.

  • ASK DOCTOR

    Ask a doctor before use if you have

    • A severe throat accompanied by difficulty in breathing or that last more than 2 days
    • A severe throat accompanied by fever, headache, rash, swealling, nausea or vomiting.
  • STOP USE

    Stop use and consult doctor if

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

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

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children.

  • OVERDOSAGE

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

  • DOSAGE & ADMINISTRATION

    Directions

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

    Other information

    • Store in a cool and dry place
  • INACTIVE INGREDIENT

    corn syrup, sucrose, water, eucalyptus oil, acacia, FD&Blue No.1

    Back Label

  • QUESTIONS

    Questions or comments call: 1-888-423-0139

  • PRINCIPAL DISPLAY PANEL

    Front Label

  • INGREDIENTS AND APPEARANCE
    MENTHOL VAPOR COUGH DROPS 
    menthol pastille
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72628-108
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL20 mg
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ACACIA (UNII: 5C5403N26O)  
    Product Characteristics
    Colorblue (Clear with internal blue glitter) Scorescore with uneven pieces
    ShapeOVALSize25mm
    FlavorMENTHOL (and eucalyptus) Imprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72628-108-0145 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(72628-108) , label(72628-108)
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