Label: GREEN GUARD HONEY LEMON COUGH DROP- menthol 8.6 mg lozenge

  • NDC Code(s): 47682-040-25, 47682-040-50
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 15, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each drop)

    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.

    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 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

    ■ 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

    ■ 15 calories per drop

    ■ store at 59º-86ºF (15º-30ºC)

    ■ protect from moisture & heat

  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Questions or comments? 1-800-869-6970

  • Green Guard Honey Lemon Cough Drop Label

    Green Guard®

    Honey Lemon

    Cough Drop relief™

    Pull to Open

    Tire Para Abrir

    Menthol 8.6mg/Mentol 8.6mg

    Cough Supressant/ Anesthetic

    Suprime la tos/ anestesico

    Pastillas par la tos

    sabor miel y limon

    Distributed by Green Guard®, St. Louis, MO 63045

    50 Drops

    Order #2243

    040B Honey

  • INGREDIENTS AND APPEARANCE
    GREEN GUARD HONEY LEMON COUGH DROP 
    menthol 8.6 mg lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-040
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    HONEY (UNII: Y9H1V576FH)  
    LEMON OIL (UNII: I9GRO824LL)  
    SUCROSE (UNII: C151H8M554)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize22mm
    FlavorHONEY (Lemon) Imprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-040-25125 in 1 BOX; Type 0: Not a Combination Product07/01/2019
    2NDC:47682-040-5050 in 1 BOX; Type 0: Not a Combination Product07/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/01/2019
    Labeler - Unifirst First Aid Corporation (832947092)
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