REDICARE CHERRY MENTHOL COUGH DROPS (CHERRY MENTHOL COUGH DROPS) LOZENGE [REDICARE LLC]

REDICARE CHERRY MENTHOL COUGH DROPS (CHERRY MENTHOL COUGH DROPS) LOZENGE [REDICARE LLC]
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NDC 71105-003-01, 71105-003-02
Set ID 66ed9f7b-e1c3-42cc-e053-2991aa0aa3a7
Category HUMAN OTC DRUG LABEL
Packager Redicare LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • Active Ingredient

    Menthol 6.1mg

  • Purpose

    Antitussive (cough suppressant)

  • Uses:

    temporarily relieves a cough due to minor throat and bronchial irritation associated with the common cold.

  • Warnings:

  • Ask a doctor before use if you have:

    • A 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:

    • a cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or a persistent headache. A persistent cough may be a sign of a serious condition.
    • a sore throat is severe, persists for more than 2 days, is accompanied by or followed by fever, headache, rash, swelling, nausea, vomiting.
  • If pregnant or breastfeeding baby,

    ask a health professional before use.

  • KEEP THIS AND ALL DRUGS

    OUT OF REACH OF CHILDREN

  • Directions

    Adults and children 12 years and over: Allow lozenge to dissolve slowly in the mouth; may be repeated every hour as necessary or as directed by a doctor.

    Children under 12 years of age: Ask a doctor

  • Other information

    • 15 calories per drop
    • Store at controlled room temperature 15 degrees to 30 degrees Celsius (59-86 degrees Fahrenheit)
    • protect from moisture and heat
  • Inactive ingredients

    artificial flavor, corn syrup, FD&C red#40, oil of eucalyptus, sugar

  • PRINCIPAL DISPLAY PANEL

    Cough Drops

  • INGREDIENTS AND APPEARANCE
    REDICARE CHERRY MENTHOL COUGH DROPS 
    cherry menthol cough drops lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71105-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6.1 mg  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SUCROSE (UNII: C151H8M554)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize20mm
    FlavorCHERRYImprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71105-003-0250 in 1 BOX03/08/2018
    1NDC:71105-003-011 in 1 PACKET; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/08/2018
    Labeler - Redicare LLC (800149346)

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