Label: KEPTRILS- 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 September 4, 2015

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  • Actives

    Menthol 5mg in each Lozenge

  • Inactives

    Honey, Citric Acid, Hyssop,Eucalyptus oil, Long pepper

  • Purpose

    Oral Analgesic

  • Uses

    Sore throat pain

    Sore mouth

    Minor mouth irritation

  • Directions

    Adults and childrens 6 years older: allow lozene to dissolve slowly in the mouth; may be repeated every two hours as nedded or as directed by doctor or dentist .

    Childrens under 6 years of age; do not use.

  • Warnings

    Sore throat warninings : Server or persistent sore throat or sore throat accomapnied by high fever headache,nausea and vomittin may be serious. Consult a doctor promptly. Do not use for more than two days or gice to children under 6  years of age. 

  • Keep out of reach of children

    Keep this and all drugs out of reach of children

  • Product Label

    keptril

  • INGREDIENTS AND APPEARANCE
    KEPTRILS 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59240-004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    HONEY (UNII: Y9H1V576FH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYSSOP OIL (UNII: 173D71924B)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LONG PEPPER (UNII: 2NMG4EA7B1)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize24mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59240-004-0124 in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/03/2015
    Labeler - MAGVERZ INC (078712269)
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