Label: LEADER SUGAR FREE COUGH DROPS BLACK CHERRY- 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 November 25, 2013

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  • LEADER Sugar Free Cough Drops Black Cherry


  • Active ingredient (in each drop)

    Menthol 5.8 mg

    Purpose

    Cough suppressant/Oral anesthetic

  • Uses

    temporarily 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 be 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 1 drop to dissolve slowly in mouth.
    May be replaced 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:

    acesulfame potassium, blue no. 1, eucalyptus oil, flavoring, hydrogenated starch hydrolysate, isomalt, red no. 40, sucralose and water. Soybean oil used as a processing aid.

  • Questions?

    Or to report an adverse event call 1-800-200-6313. Monday - Friday, 9AM to 4PM EST

  • DISTRIBUTED BY

    CARDINAL HEALTH DUBLIN, OHIO 43017 CIN 4562393 www.myleader.com 1-800-200-6313

    UD Certified GF Gluten-Free

    * This product is not manufactured or distributed by Kraft, owner of the registered trademark HallsR, or by any of its affiliates.

  • LEADER Sugar Free Cough Drops Black Cherry 25 Count (49781-043-25)

    Front 49781-043Back 49781-043

  • INGREDIENTS AND APPEARANCE
    LEADER SUGAR FREE COUGH DROPS BLACK CHERRY 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-043
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    ISOMALT (UNII: S870P55O2W)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize12mm
    FlavorCHERRY (Black Cherry) Imprint Code B
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49781-043-2525 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/25/2013
    Labeler - Cardinal Health (097537435)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bestco, Inc.002149136manufacture(49781-043)
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