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
  • 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 November 1, 2022

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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 finalpart34107/01/2019
    Labeler - Unifirst First Aid Corporation (832947092)
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