Label: COUGH DROPS- menthol pastille

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 3, 2023

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  • ACTIVE INGREDIENT

    Active ingredient 7.5 mg

    Cough Suppressant

    Oral anesthetic

    Front Panel

  • PURPOSE

    Uses temporarily relieves:

    • cough as may occur with a cold
    • ocassional minor irritation and sore throat
  • INDICATIONS & USAGE

    Uses temporarily relieves:

    • cough as may occur with a cold
    • ocassional minor irritation and sore throat

  • WARNINGS

    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 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
    • 10 calories per drop
  • INACTIVE INGREDIENT

    citric acid, honey, flavors, glucose syrup, sucrose, turmeric

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    Back

  • INGREDIENTS AND APPEARANCE
    COUGH DROPS 
    menthol pastille
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-025
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    SUCROSE (UNII: C151H8M554)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HONEY (UNII: Y9H1V576FH)  
    TURMERIC (UNII: 856YO1Z64F)  
    Product Characteristics
    ColoryellowScorescore with uneven pieces
    ShapeOVALSize25mm
    FlavorHONEYImprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-025-0180 in 1 BAG; Type 0: Not a Combination Product10/03/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/14/2022
    Labeler - Topco Associates LLC (006935977)
    Registrant - Boston Nutraceutical Science SL (466061824)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boston Nutraceutical Production SL468121064label(76162-025) , pack(76162-025) , manufacture(76162-025)
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