Label: GEMS CHERRY- menthol lozenge

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 23, 2023

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  • Active ingredient (in each drop)

    Menthol 7 mg

  • Purpose

    Cough suppressant/oral anesthetic

  • Uses

    temporarily relieves:

    • cough due to a cold
    • occasional minor irritation or sore throat
  • Warnings

    Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, swelling, nausea, or vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days unless directed by a 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 and ask a doctor if

    • sore mouth does not improve in 7 days
    • 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.
    • irritation, pain, or redness persists or worsens

    Keep out of reach of children.

  • Directions

    • do not take more than directed
    • adults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.
    • children under 5 years: ask a doctor
  • Other information

    • 12 calories per drop
    • Contains: SOY
  • Inactive ingredients

    corn syrup, eucalyptus oil, FD&C red #40, natural & artificial flavors, soy lecithin, sucrose, water

  • Principal display panel

    Menthol • Cough Suppressant • Oral Anesthetic

    Gems™

    CHERRY
    FLAVOR

    9 DROPS

    Distributed by Gems™ Drops, LLC,
    Hauppauge, NY 11788 1-844-632-7898

    Gems 44-172

    Gems 44-172


  • INGREDIENTS AND APPEARANCE
    GEMS  CHERRY
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71165-172
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScoreno score
    ShapeSQUARESize18mm
    FlavorCHERRYImprint Code G
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71165-172-029 in 1 PACKAGE; Type 0: Not a Combination Product09/13/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/13/2021
    Labeler - Riclan S.A. (911989788)
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