Label: HONEY LEMON COUGH DROPS- menthol pastille

  • 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 September 4, 2019

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  • ACTIVE INGREDIENT

    Active Ingredient in each drop Purposes

    Menthol 7.6 mg Cough Suppressant

    Oral anesthetic

    Front package

  • PURPOSE

    Purposes

    Cough suppressant/

    Oral anesthetic

  • INDICATIONS & USAGE

    Uses Temporarily relieves:

    • cough as may occur with cold or inhaled irritants
    • ocassional minor irritations and sore throat

  • WARNINGS

    Warnings

    Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swealing, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms 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 emphysema

    cough accompanied by excessvie phlegm (mucus)

  • STOP USE

    Stop use and consult 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 throat is severe, or irritation, pain or redness last 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 5 years and over: allow 1 drop to dissolve slowly in mouth. May be repeated every two hours as necessary or as directed by a doctor.
    • Children under 5 years: ask a doctor
  • OTHER SAFETY INFORMATION

    Other information

    • 6 calories per drop
    • May be useful for diabetics on the advise of a doctor
    • Excessive consumption may cause laxative effect
  • INACTIVE INGREDIENT

    Citric acid, eucalyptus oil, isomalt, stevia, flavor lemon oil, flavor honey extract, colorant turmeric, water

    Back label

  • QUESTIONS

    Questions or comments call: 617-848-4560

  • PRINCIPAL DISPLAY PANEL

    Front panel

  • INGREDIENTS AND APPEARANCE
    HONEY LEMON COUGH DROPS 
    menthol pastille
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72628-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LEMON OIL (UNII: I9GRO824LL)  
    HONEY (UNII: Y9H1V576FH)  
    ISOMALT (UNII: S870P55O2W)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)  
    TURMERIC (UNII: 856YO1Z64F)  
    Product Characteristics
    ColoryellowScorescore with uneven pieces
    ShapeOVALSize17mm
    FlavorHONEY, LEMONImprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72628-101-0125 in 1 BAG; Type 0: Not a Combination Product03/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/26/2019
    Labeler - Boston Nutraceutical Production SL (468121064)
    Registrant - Boston Nutraceutical Science SL (466061824)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boston Nutraceutical Production SL468121064manufacture(72628-101) , label(72628-101) , pack(72628-101)
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