Label: CRANE SAFETY CHERRY COUGH DROPS- menthol 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 January 25, 2022

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each drop)

    Menthol 7.6 mg

  • PURPOSE

    Purpose

    Antitussive (cough suppressant)/oral anesthetic

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves

    • cough as may occur with a cold or inhaled irritants
    • occasional minor irritation and sore throat
  • WARNINGS

    Warnings

    Sore throat warning:

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. These symptoms may be serious.

  • ASK 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

    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
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • do not use more than directed

    Adults and children:
    (12 years and older)

    Allow 1 drop to dissolve slowly in the mouth. May be repeated every 2 hours as necessary or as directed by a doctor.

    Children under 12 years:

    ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • 15 calories per drop
    • store at 59-86°F (15°-30°C)
    • protect from moisture & heat
  • INACTIVE INGREDIENT

    Inactive ingredients

    cherry flavor, corn syrup, eucalyptus oil, FD&C red #40 lake, sucrose

  • QUESTIONS

    Questions or comments? 877.506.4291

  • Crane Safety Cherry Cough Drops Label

    Cherry Cough Drops

    Cough Suppressant/Oral Anesthetic

    CRANE Safety®

    Pull to Open

    Menthol 7.6 MG

    50/Box

    Individually Wrapped Lozenges

    050B

  • INGREDIENTS AND APPEARANCE
    CRANE SAFETY CHERRY COUGH DROPS 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73408-915(NDC:47682-915)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize22mm
    FlavorCHERRYImprint Code P
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73408-915-5050 in 1 BOX01/17/202009/30/2024
    11 in 1 CELLO PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/17/202009/30/2024
    Labeler - Crane Safety LLC (080998015)
    Registrant - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761relabel(73408-915) , repack(73408-915)
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