Label: LEADER THROAT SOOTHING DROPS CREAMY STRAWBERRY- throat soothing creamy strawberry lozenge

  • NDC Code(s): 70000-0711-1
  • Packager: Cardinal Health 110, LLC. DBA Leader
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2024

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  • DRUG FACTS

  • Active ingredient (per drop)

    Pectin 7 mg

  • Purposes

    oral demulcent

  • Uses

    For temporary relief of minor discomfort and protection of irritated areas in 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.

    If sore mouth symptoms do not improve in 7 days, see your dentist or doctor promptly.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • adults and children 5 years and over: dissolve lozenge slowly in the mouth. Repeat every 2 hours as needed or as directed by a doctor. • children under 5 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, citric acid, corn syrup, FD&C blue 2, FD&C red 40, lactic acid, malic acid, potassium citrate, soy lecithin, strawberry flavor, sucrose, sucralose, titanium dioxide, water.

  • Questions?

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

  • Packaging

    Label

  • INGREDIENTS AND APPEARANCE
    LEADER THROAT SOOTHING DROPS CREAMY STRAWBERRY 
    throat soothing creamy strawberry lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0711
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN7 mg
    Inactive Ingredients
    Ingredient NameStrength
    BETA CAROTENE (UNII: 01YAE03M7J)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    MALIC ACID (UNII: 817L1N4CKP)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    SOYBEAN LECITHIN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite, redScoreno score
    ShapeOVALSize21mm
    FlavorSTRAWBERRY (Creamy Strawberry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0711-130 in 1 BAG; Type 0: Not a Combination Product11/08/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/08/2024
    Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
    Registrant - Medical Group Care LLC (085137089)
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