Label: NATURAL HERB COUGH DROPS- menthol herb pastille

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

Drug Label Information

Updated October 7, 2024

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

  • ACTIVE INGREDIENT

    Active Ingredient:

    • Menthol 4.8 mg.............cough suppresant/ oral anesthetic
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  • 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 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 as a Doctor
  • OTHER SAFETY INFORMATION

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

    caramel color, blend of herb extracts (elderflower, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme. wild thyme) glucose syrup, natural flavors, sucrose

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  • QUESTIONS

    Questions? or to report and adverse event call: 1-833-552-1767

  • PRINCIPAL DISPLAY PANEL

    Back

  • INGREDIENTS AND APPEARANCE
    NATURAL HERB COUGH DROPS 
    menthol herb pastille
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-850
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERMINT (UNII: V95R5KMY2B)  
    HOREHOUND (UNII: K08036XEJV)  
    MELISSA OFFICINALIS FLOWER (UNII: RCU5REA2I1)  
    THYME (UNII: CW657OBU4N)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    SAGE (UNII: 065C5D077J)  
    MALVA SYLVESTRIS LEAF (UNII: 17H39B00T5)  
    CARAMEL (UNII: T9D99G2B1R)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    SUCROSE (UNII: C151H8M554)  
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
    HYSSOPUS OFFICINALIS FLOWERING TOP (UNII: X7HKN4FOJI)  
    WILD THYME (UNII: KXK6I80R8W)  
    Product Characteristics
    ColorbrownScorescore with uneven pieces
    ShapeOVALSize25mm
    FlavorMENTHOL (Herbs) Imprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-850-0160 in 1 BAG; Type 0: Not a Combination Product05/29/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/29/2023
    Labeler - CVS Pharmacy (062312574)
    Registrant - Boston Nutraceutical Science SL (466061824)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boston Nutraceutical Production SL468121064manufacture(51316-850) , label(51316-850) , pack(51316-850)