Label: REDICARE CHERRY MENTHOL COUGH DROPS- cherry menthol cough drops lozenge

  • 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 July 2, 2021

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  • 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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