Label: XPECT CHERRY COUGH DROPS- cherry cough drops lozenge

  • NDC Code(s): 42961-232-01, 42961-232-02, 42961-232-03
  • Packager: Cintas 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 July 19, 2023

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  • ACTIVE INGREDIENT

    Active ingredient (in each drop)

    Menthol 7 mg

  • PURPOSE

    Purpose

    Cough suppressant/oral anesthetic

  • INDICATIONS & USAGE

    Uses

    temporarily relieves:

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

    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 

    • 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

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    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 SAFETY INFORMATION

    Other information

    • 12 calories per drop
    • Contains: SOY
  • INACTIVE INGREDIENT

    Inactive ingredients 

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

  • QUESTIONS

    Questions or comments?

    1-877-973-2811 Monday - Friday 8:00 am - 5:00 pm 

  • Principal Display Panel 42961-232-02

    CHERRY COUGH DROP

    Menthol

    Cough suppressant/oral anesthetic

    • Soothes sore throat
    • Temporarily relieves cough
    • Contains a menthol cough suppressant and oral anesthetic

    Xpect® First aid

    50 Individually Wrapped Drops

    50Box

  • Principal Display Panel 42961-232-03

    CHERRY COUGH DROP

    Menthol

    Cough suppressant/oral anesthetic

    • Soothes sore throat
    • Temporarily relieves cough
    • Contains a menthol cough suppressant and oral anesthetic

    Xpect® First aid

    100 Individually Wrapped Drops

    100Box

  • INGREDIENTS AND APPEARANCE
    XPECT CHERRY COUGH DROPS 
    cherry cough drops lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-232
    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
    ShapeOVALSize17mm
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-232-0250 in 1 BOX07/19/2023
    1NDC:42961-232-011 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:42961-232-03100 in 1 BOX07/19/2023
    2NDC:42961-232-011 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/19/2023
    Labeler - Cintas Corporation (056481716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Riclan S.A.911989788manufacture(42961-232)
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