GREEN APPLE COUGH DROPS (MENTHOL, UNSPECIFIED FORM) LOZENGE [CVS]

GREEN APPLE COUGH DROPS (MENTHOL, UNSPECIFIED FORM) LOZENGE [CVS]
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NDC 59779-639-30
Set ID 871f8a9a-1f21-4985-89ce-2876cd61b67b
Category HUMAN OTC DRUG LABEL
Packager CVS
Generic Name
Product Class
Product Number
Application Number PART341
  • Drug Facts

  • Active Ingredient (in each drop)

    Menthol 2.6mg

    Purpose

    Cough suppressant/ Oral anesthetic

  • Uses

    temporarly relieves:

    • cough as may occur with a cold
    • occasional minor irritation and sore throat
  • Warnings

    Sore throat warning: ​If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, see your dentist or 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)

    When using this product

    • do not exceed recommended dosage

    Stop use and consult 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 throat is severe, or irritation, pain or redness lasts or worsens
    • sore mouth does not improve in 7 days

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep this and all drugs out of the reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 5 years and over       allow 2 drops to dissolve slowly in mouth, one at a time.  May be repeated every two hours as   necessary or as directed by a doctor.
     children under 5 years   ask a doctor.

  • Other information

    • 10 calories per drop
  • Inactive ingredients

    Beta carotene, citric acid, corn starch, eucalyptus oil, FD&C blue no. 1, glucose syrup, glycerin, medium chain triglycerides, natural flavor, soybean oil, sucrose and water. May contain these ingredients. 

  • Questions?

    Or to report an adverse event call 1-800-245-2898. Monday - Friday, 9AM to 4PM EST

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    GREEN APPLE COUGH DROPS 
    menthol, unspecified form lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-639
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    .BETA.-CAROTENE (UNII: 01YAE03M7J)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    Product Characteristics
    Colorgreen (Green) Scoreno score
    ShapeOVAL (Oval) Size22mm
    FlavorAPPLE (Green Apple) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-639-301 in 1 CARTON11/09/2015
    130 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/09/2015
    Labeler - CVS (062312574)

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