Label: HERBAL FLAVOR MENTHOL COUGH DROPS pastille

  • NDC Code(s): 42681-0039-1
  • Packager: WHOLE FOODS MARKET, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 2, 2024

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  • ACTIVE INGREDIENT

    Active ingredient 4.8 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.

  • ASK DOCTOR

    Ask a doctor before use if you have

    • persistent or chronic cough such as occurs with smoking, asthma or emphysema
    • cough accompany by excessive phem (mucus)
  • STOP USE

    Stop use and consult a doctor if

    • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash or persisten headache. These could be signs of a serious condition
    • sore mouth symptons do not improve in 7 days or if irritation, pain 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 6 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor.
    • Children under 6 years ask a doctor
  • OTHER SAFETY INFORMATION

    • Store in a cool and dry place.
    • 10 calories per drop
  • INACTIVE INGREDIENT

    glucose syrup, sugar, caramel color, natural flavor, herbal extract blend (elderflower extract, horehound extract, hyssop extract, lemon balm extract, linden flower extract, marshmallow root, peppermint extract, sage extractm thyme extract, wild thyme extract

  • QUESTIONS

    Questions? or to report and adverse event call: 1-800-936-8255

  • PRINCIPAL DISPLAY PANEL

    Back Panel

  • INGREDIENTS AND APPEARANCE
    HERBAL FLAVOR MENTHOL COUGH DROPS 
    herbal flavor menthol cough drops pastille
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42681-0039
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUGARCANE (UNII: 81H2R5AOH3)  
    CARAMEL (UNII: T9D99G2B1R)  
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    ALTHAEA OFFICINALIS FLOWER (UNII: B3911G2Q52)  
    WILD THYME (UNII: KXK6I80R8W)  
    MELISSA OFFICINALIS FLOWER (UNII: RCU5REA2I1)  
    HYSSOPUS OFFICINALIS FLOWERING TOP (UNII: X7HKN4FOJI)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    SAGE (UNII: 065C5D077J)  
    HOREHOUND (UNII: K08036XEJV)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    THYME (UNII: CW657OBU4N)  
    Product Characteristics
    ColorbrownScorescore with uneven pieces
    ShapeOVALSize25mm
    FlavorMENTHOL (Herbal) Imprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42681-0039-145 in 1 BAG; Type 0: Not a Combination Product08/02/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/02/2024
    Labeler - WHOLE FOODS MARKET, INC. (196175616)
    Registrant - Boston Nutraceutical Science SL (466061824)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boston Nutraceutical Production SL468121064label(42681-0039) , manufacture(42681-0039) , pack(42681-0039)
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