Label: MENTHOL- cough suppressant lozenge

  • Category: HUMAN OTC DRUG LABEL

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 October 21, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient
    Menthol 8.6 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.

  • STOP USE

    Ask a doctor if you have
    ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    ■ cough accompanied by excessive phlegm (mucus)

  • STOP USE

    Stop us e 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

    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 us e 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:

    • Do not give to children under 12 years of age.
  • OTHER SAFETY INFORMATION

    Other information
    ■ 15 calories per drop
    ■ store at 59º-86ºF (15º-30ºC)
    ■ protect from moisture & heat

  • INACTIVE INGREDIENT

    Inactive ingredients
    corn syrup, D&C yellow # 10, eucalyptus oil, FD&C yellow # 6, honey, lemon oil, sucrose

  • QUESTIONS

    Questions? Call 1-800-777-4908

  • PRINCIPAL DISPLAY PANEL

    27996LNDC# 68599-0465-9
    McKesson
    Cough Drops Assorted
    Honey Lemon
    250 per Jar
    MFR# 27996L

  • INGREDIENTS AND APPEARANCE
    MENTHOL 
    cough suppressant lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-0465
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.86 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LEMON OIL (UNII: I9GRO824LL)  
    SUCROSE (UNII: C151H8M554)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    HONEY (UNII: Y9H1V576FH)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    Product Characteristics
    Coloryellow (Translucent) Scorescore with uneven pieces
    ShapeOVALSize23mm
    FlavorHONEY (Lemon) Imprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-0465-90.86 g in 1 JAR; Type 0: Not a Combination Product01/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/30/2020
    Labeler - McKesson (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaloz Manufacturing, Inc.067101998manufacture(68599-0465)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761pack(68599-0465)
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