Label: BENTASIL SUGAR FREE HONEY LEMON SOFT TEXTURE- menthol lozenge

  • 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 April 17, 2014

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  • Active Ingredient

    Menthol 5mg

  • Purpose

    Cough Suppressant, Oral Anesthetic

  • Uses

    •for the temporary relief of minor sore throat

    •for the temporary relief of coughs due to a cold

  • Warnings

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These symptoms may be serious.

  • Ask a doctor before use if you have

    •persistent or chronic cough such as occurs with smoking, asthma, or emphysema

    •cough accompanied by excessive phlegm (mucus)

  • When using this product

    •do not exceed recommended dosage

  • Stop use and ask a doctor if

    •cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    •sore mouth does not improve in 7 days or irritation, pain or redness persists or worsens

  • Keep out of reach of children

  • Directions

    •adults and children 5 years and over: slowly dissolve one drop in the mouth. May be repeated every 2 hours as needed. 

    •children under 5 years: ask a doctor

  • Other Information

    • 3.1 calories per drop

  • Inactive Ingredients

    •Ammonium glycrrhizate, carnauba wax, coconut and or palm kernel oil, flavoring, gum arabic, maltitol, sorbitol

  • Product Label

    image description

  • INGREDIENTS AND APPEARANCE
    BENTASIL  SUGAR FREE HONEY LEMON SOFT TEXTURE
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63104-004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    PALM KERNEL OIL (UNII: B0S90M0233)  
    ACACIA (UNII: 5C5403N26O)  
    MALTITOL (UNII: D65DG142WK)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Coloryellow (Amber) Scoreno score
    ShapeROUND (Lozenge) Size19mm
    FlavorHONEY (Honey and Lemon) Imprint Code NONE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63104-004-2020 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/01/2014
    Labeler - CLOETTA ITALIA S.r.l. (565049314)
    Establishment
    NameAddressID/FEIBusiness Operations
    CLOETTA ITALY SAN PIETRO IN CASALE PLANT378806215manufacture(63104-004)
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