Label: LEADER COUGH DROPS VANILLA HONEY- menthol lozenge

  • NDC Code(s): 83698-692-30
  • Packager: Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 11, 2024

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  • Drug Facts

  • Active ingredient (in each lozenge)

    Menthol 2.5 mg

  • Purposes

    Cough suppressant/oral anesthetic

  • Uses

    temporarily relieves:
    • cough due to a cold • occasional minor irritation, pain, sore mouth, and sore throat

  • Warnings

    Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

    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)

    When using this productdo not exceed recommended dosage

    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. A persistent cough may be a sign of a serious condition
    • sore mouth symptoms do not improve in 7 days
    • irritation, pain, or redness persists or worsens

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

  • Directions

    • adults and children 2 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor
    • children under 2 years of age: ask a doctor

  • Other information

    • store at room temperature.
    • keep away from excessive heat or sunlight
    • do not use if primary bag seal has been torn or broken.
    • contains: SOY

  • Inactive ingredients

    beta carotene, corn syrup, honey, soy lecithin, sucrose, vanilla flavor, water.

  • Questions or comments?

    Call +1-866-306-9136
    You may also report concerns to this phone number
    Monday to Friday, 9 AM -5 PM Eastern Time 

  • SPL UNCLASSIFIED SECTION

    RESEALABLE BAG

    Gluten and Dairy-Free

    Soothing Drops

    COMPARE TO HALLS® active ingredient*

    CLOSE BAG TO MAINTAIN FRESHNESS

    CardinalHealth™

    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OHIO 43017
    www.myleader.com   1-800-200-6313
    Essential to Care™ Since 1979

    Made in China

    ©2024 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

    *This product is not manufactured or distributed by Intercontinental Great Brands LLC., owner of the registered trademark HALLS ®.

    Contains 10 calories per lozenge

    CHOKING WARNING: SMALL PARTS CHOKING HAZARD FOR CHILDREN UNDER 4. CHILDREN SHOULD ALWAYS BE SEATED AND SUPERVISED WHILE EATING.

    All LEADER™ Brand Products Have A 100% Money Back Guarantee
    Return to place of purchase if not satisfied.

  • Packaging

    Vanilla Honey

  • INGREDIENTS AND APPEARANCE
    LEADER COUGH DROPS VANILLA HONEY 
    menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83698-692
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    BETA CAROTENE (UNII: 01YAE03M7J)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    HONEY (UNII: Y9H1V576FH)  
    SOYBEAN LECITHIN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Coloryellow (amber) Scoreno score
    ShapeOVALSize21mm
    FlavorVANILLA, HONEYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83698-692-3030 in 1 BAG; Type 0: Not a Combination Product07/10/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/10/2024
    Labeler - Xiamen Kang Zhongyuan Biotechnology Co., Ltd. (411759931)
    Registrant - Medical Group Care LLC (085137089)
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