Label: SEVERE THROAT SORE DROPS- menthol pastille

  • 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 October 10, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient in each drop Purposes

    Menthol 20mg Cough Suppressant

    Oral anesthetic

  • PURPOSE

    Temporarily relieves ocassional minor irritation and pain due to:

    • sore throat
    • sore mouth
  • INDICATIONS & USAGE

    Temporarily relieves ocassional minor irritation and pain due to:

    • sore throat
    • sore mouth

  • WARNINGS

    Warnings

    Sore throat warning: severe or persistence sore throat accompanied or followed 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 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 sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting
  • STOP USE

    Stop use and consult a doctor if

    • sore mouth symptons do not improve in 7 days or if irritation, pains or redness persists or worsens.
  • 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 2 hours as needed or as directed by a doctor.
    • Children under 12 years and under do not use
  • OTHER SAFETY INFORMATION

    • Store in a cool and dry place
  • INACTIVE INGREDIENT

    eucalyptus oil, FD&C Blue No.1, glucose syrup, gum arabic, sucrose

    Back Label

  • QUESTIONS

    Questions? or to report and adverse event call: 1-617-848-4560

    Monday to Friday 9AM to 4 PM east

  • PRINCIPAL DISPLAY PANEL

    Front Label

  • INGREDIENTS AND APPEARANCE
    SEVERE THROAT SORE DROPS 
    menthol pastille
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-143
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.69 mg
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    ACACIA (UNII: 5C5403N26O)  
    SUCROSE (UNII: C151H8M554)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    Product Characteristics
    Colorwhite (with menthol drops) Scorescore with uneven pieces
    ShapeRECTANGLESize17mm
    FlavorMENTHOLImprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-143-0145 in 1 BAG; Type 0: Not a Combination Product10/12/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/12/2019
    Labeler - Target Corporation Inc. (006961700)
    Registrant - Boston Nutraceutical Science SL (466061824)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boston Nutraceutical Production SL468121064manufacture(11673-143) , label(11673-143) , pack(11673-143)