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
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 6, 2023

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  • 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 finalpart34105/12/2021
    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)
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