Label: GREEN GUARD COUGH DROP RELIEF- menthol lozenge

  • NDC Code(s): 47682-018-25, 47682-018-50
  • 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 March 15, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each drop)

    Menthol 7.6 mg

  • PURPOSE

    Purpose

    Anititussive (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

    If pregnant or breast-feeding, ask a health professional before use.

    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

  • SPL UNCLASSIFIED SECTION

    Other information

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

    Inactive ingredients

    cherry flavor, corn syrup, eucalyptus oil, FD&C red #40, sucrose

  • QUESTIONS

    Questions or comments? 1-800-869-6970

  • Green Guard Cough Drop Label

    Green Guard Cough Drop Relief Label

    Medicated Cherry

    Cough Drop relief

    Green Guard ®

    Pull To Open

    Tire Para Abrir

    Menthol 7.6mg

    Mentol 7.6mg

    Cough Supressant/Anethetic

    Suprime la tos/anestesico

    125 Drops

    Order #2242

    Distributed by Green Guard®, St Louis, MO 63045

    GG Cherry

  • INGREDIENTS AND APPEARANCE
    GREEN GUARD COUGH DROP RELIEF 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-018
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorred (red) Scoreno score
    ShapeOVAL (OVAL) Size22mm
    FlavorCHERRY (Cherry) Imprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-018-5050 in 1 BOX; Type 0: Not a Combination Product11/01/2011
    2NDC:47682-018-25125 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)
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