Label: LUDENS HONEY LEMON- pectin lozenge

  • NDC Code(s): 52183-220-25, 52183-220-90
  • Packager: Prestige Brands Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 February 25, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each drop)

    Pectin 2.8 mg

  • Purpose

    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. These may be serious.

    Stop use and ask a doctor if

    • sore mouth does not improve in 7 days
    • irritation, pain or redness persists or worsens

    Keep out of reach of children

  • Directions

    • adults and children 3 years of age and older: allow one drop to dissolve slowly in mouth
      ▪ may be repeated as needed or as directed by a doctor
    • children under 3 years of age: ask a doctor
  • Other information

    • store at 20º-25ºC (68º-77ºF) in a dry place
    • Contains FD&C yellow no. 5 (tartrazine) as a color additive
  • Inactive ingredients

    ascorbic acid, citric acid, corn syrup, FD&C yellow no. 5, honey, lemon oil, sodium acetate, sodium chloride, sucrose, water

  • Questions?

    1-866-583-3677  Ludens.com

  • PRINCIPAL DISPLAY PANEL

    Luden’s ® 

    Honey Lemon

    Pectin lozenge/ oral demulcent

    25 Throat Drops

    Luden’s ® 

    Honey Lemon

    Pectin lozenge/ oral demulcent      

    90 Throat Drops

    PRINCIPAL DISPLAY PANEL Luden’s ® Honey Lemon Pectin lozenge/ oral demulcent 25 Throat Drops Luden’s ® Honey Lemon Pectin lozenge/ oral demulcent 90 Throat Drops

  • INGREDIENTS AND APPEARANCE
    LUDENS HONEY LEMON 
    pectin lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-220
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN2.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    HONEY (UNII: Y9H1V576FH)  
    LEMON OIL (UNII: I9GRO824LL)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeOVALSize23mm
    FlavorLEMON, HONEYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52183-220-2525 in 1 BAG; Type 0: Not a Combination Product02/01/2018
    2NDC:52183-220-9090 in 1 BAG; Type 0: Not a Combination Product02/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35602/01/2018
    Labeler - Prestige Brands Holdings, Inc. (159655021)
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