Label: NATURAL HERBAL COUGH DROPS- menthol pastille

  • NDC Code(s): 72628-111-01
  • Packager: BOSTON NUTRACEUTICAL PRODUCTION, S.L
  • 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 in each drop Purposes

    Menthol 4.8 mg

    Cough Suppressant

    Oral Anesthetic

    Back Label

  • PURPOSE

    Purposes

    Temporarily relieves :

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

    Purposes

    Temporarily relieves :

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

  • WARNINGS

    Warnings

    Sore throat warning: is sore throat is severe, persist for more than 2 days, is accompanied or followed by fever headache, rash, swelling, nausea and vomiting maybe serious consult a doctor promptly. If sore mouth symptons do not improve in 7 days, see your dentist or doctor promptly. These symptons may be serious

  • ASK DOCTOR

    Ask a doctor before use if you have

    • Persistent or chronic cough such as occurs with smoking, asthma or ephysema.
    • Cough accompanied by excessive pleghm (mucus)
  • STOP USE

    Stop use and consult doctor if

    • cough persist for more than 7 days or tends to recur or is accompanied by fever, rash or persistent headache. These could be signs of a serious conditions
    • sore throat is severe or irritation, pain or redness lasts or worsens.
    • sore mouth does not improve in 7 days
  • 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: allow 2 drops to dissolve slowly in mouth one at a time. Maybe repeated every two hours as needed or as directed by a doctor.
    • Children under 6 years ask a doctor
  • OTHER SAFETY INFORMATION

    Other information

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

    glucose syrup, sucrose, caramel color, elderflower, honehound, hyssop, lemon balm, liden fiwer, malow, peppermint, sage, thyme, wild thyme, natural flavours

  • QUESTIONS

    Questions or to report an adverse event call:

    1 800 632 6800

  • PRINCIPAL DISPLAY PANEL

    Package

  • INGREDIENTS AND APPEARANCE
    NATURAL HERBAL COUGH DROPS 
    menthol pastille
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72628-111
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    LEMON BALM OIL (UNII: MJ76269K9S)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    HYSSOPUS OFFICINALIS FLOWERING TOP (UNII: X7HKN4FOJI)  
    SAGE (UNII: 065C5D077J)  
    THYME (UNII: CW657OBU4N)  
    WILD THYME (UNII: KXK6I80R8W)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    CARAMEL (UNII: T9D99G2B1R)  
    HOREHOUND (UNII: K08036XEJV)  
    SUCROSE (UNII: C151H8M554)  
    MALVA NEGLECTA WHOLE (UNII: S0QQA41760)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
    Product Characteristics
    Colorbrown (dark) Scorescore with uneven pieces
    ShapeOVALSize25mm
    FlavorMENTHOL (and herbal) Imprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72628-111-0150 in 1 BAG; Type 0: Not a Combination Product05/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/12/2021
    Labeler - BOSTON NUTRACEUTICAL PRODUCTION, S.L (468121064)
    Registrant - Boston Nutraceutical Science SL (466061824)
    Establishment
    NameAddressID/FEIBusiness Operations
    BOSTON NUTRACEUTICAL PRODUCTION, S.L468121064manufacture(72628-111) , label(72628-111)