Label: MEDIQUE SUGAR FREE MEDIKOFF DROPS- menthol lozenge

  • NDC Code(s): 47682-110-03, 47682-110-05
  • Packager: Unifirst First Aid Corporation
  • 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 March 24, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each drop)

    Menthol 5.8 mg

  • PURPOSE

    Purpose

    Antitussive (cough suppressant)/oral anesthetic

  • INDICATIONS & USAGE

    Uses

    temporarily relieves

    ■ cough as may occur with a cold or inhaled irritants

    ■ occasional minor irritation 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, 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)
  • STOP USE

    Stop use and ask a 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 mouth does not improve in 7 days
    • irritation, pain, or redness persists or worsens
  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not use more than directed

    ​Adults and Children (12 years and older)

    ​Allow 1 drop to dissolve slowly in the mouth. May be repeated every 2 hours as necessary or as directed by a doctor.

    Children under 12 years: Ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • 7 calories per drop
    • store at 59º-86ºF (15º-30ºC)
    • protect from moisture & heat
  • INACTIVE INGREDIENT

    Inactive ingredients

    acesulfame potassium, eucalyptus oil, flavoring, isomalt

  • QUESTIONS

    Questions or comments? 1-800-634-7680

  • Medique Medikoff Sugar Free

    Medique ®

    Sugar Free Medikoff Drops

    Vapor Action with Eucalyptus

    Accion Vaporizante con Eucalypto

    Cough Supressant/Anesthetic • Menthol 5.8mg

    Suprima la tos/anestesico • Mentol 5.8 mg

    Pull to Open

    Tire Para Abrir

    300 Lozenges

    300 Pastillas

    Individually Wrapped Cough Drops

    Individualmento envuelto pastillas para la tos

    Collect MediBucks

    See inside flap for more details

    109R MedikoffSFree

  • INGREDIENTS AND APPEARANCE
    MEDIQUE SUGAR FREE MEDIKOFF DROPS 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-110
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ISOMALT (UNII: S870P55O2W)  
    Product Characteristics
    Colorwhite (translucent) Scoreno score
    ShapeOVAL (OVAL) Size23mm
    FlavorImprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-110-03300 in 1 BOX; Type 0: Not a Combination Product11/01/2011
    2NDC:47682-110-055 in 1 BOX; Type 0: Not a Combination Product11/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/01/2011
    Labeler - Unifirst First Aid Corporation (832947092)
    Registrant - Unifirst First Aid Corporation (832947092)
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