Label: MCKESSON SUGAR FREE COUGH SUPPRESSANT ORAL ANESTHETIC- menthol lozenge lozenge

  • NDC Code(s): 68599-1090-3
  • Packager: McKesson Medical-Surgical
  • 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 June 7, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each lozenge)

    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 DOCTOR

    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 over)

    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? Call 1-800-777-4908

  • PRINCIPAL DISPLAY PANEL

    NDC 68599-1090-3

    McKesson

    Sugar Free Cough Suppressant Oral Anesthetic Drops

    Menthol Flavored

    Each Lozenge Contains Menthol 5.8 mg

    Temporarily relieves coughs due to colds and minor sore throat pain.

    300

    Lozenges

    Per Box

    MFR # 98006

    109R

  • INGREDIENTS AND APPEARANCE
    MCKESSON SUGAR FREE COUGH SUPPRESSANT ORAL ANESTHETIC 
    menthol lozenge lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-1090
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ISOMALT (UNII: S870P55O2W)  
    Product Characteristics
    Colorwhite (translucent) Scoreno score
    ShapeOVALSize23mm
    FlavorMENTHOLImprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-1090-3300 in 1 BOX; Type 0: Not a Combination Product09/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/01/2022
    Labeler - McKesson Medical-Surgical (023904428)
    Registrant - Unifirst First Aid Corporation (832947092)
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