Label: HERBAL COUGH DROPS ORIGINAL HERB- cough drops pastille

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

Drug Label Information

Updated March 6, 2025

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  • USES

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

    Active Ingredient

    Menthol 4.8 mg

  • Stop and Consult a Doctor if

    • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash or persistent 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.
  • If pregnant or breast-feeding

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

  • Keep out of the reach of children

    Keep out of the reach of chilcren. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Questions?

    Questions? or to report an adverse event call 1-888-423-0139

  • When using this product

    When using this product

    • do not exceed recomended dosage
  • Other information

    Other information

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

    Warnings

    Sore throat warning: Severe or persisten sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days.

  • Inactive Ingredients

    Back PanelElderflower, Horehound, Hyssop, Lemon balm, Linden flowers, Mallow, Peppermint, Sage, Thyme, Wild thyme, Glucose syrup, Sucrose, Caramel color, Natural flavors

  • Directions

    • Adults and children 6 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed or as directed by the doctor
    • Children under 6 years: as a doctor
  • Indications & Usage Section

    Uses temporarily relieves:

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

    Frontal

  • INGREDIENTS AND APPEARANCE
    HERBAL COUGH DROPS ORIGINAL HERB 
    cough drops pastille
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-061
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
    LEMON BALM OIL (UNII: MJ76269K9S)  
    THYME (UNII: CW657OBU4N)  
    CARAMEL (UNII: T9D99G2B1R)  
    FLAVONE (UNII: S2V45N7G3B)  
    SUCROSE (UNII: C151H8M554)  
    GLUCOSE (UNII: 5SL0G7R0OK)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    MALVA NEGLECTA WHOLE (UNII: S0QQA41760)  
    WILD THYME (UNII: KXK6I80R8W)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    SAGE (UNII: 065C5D077J)  
    HYSSOPUS OFFICINALIS WHOLE (UNII: 0IQW001KPE)  
    HOREHOUND (UNII: K08036XEJV)  
    Product Characteristics
    ColorbrownScorescore with uneven pieces
    ShapeOVALSize25mm
    FlavorMENTHOL (Herbal) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-061-0145 in 1 BAG; Type 0: Not a Combination Product03/05/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/05/2025
    Labeler - Topco Associates LLC (006935977)
    Registrant - Boston Nutraceutical Science SL (466061824)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boston Nutraceutical Production SL468121064label(76162-061) , pack(76162-061) , manufacture(76162-061)
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