LUDENS HONEY LEMON (PECTIN) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]

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LUDENS HONEY LEMON (PECTIN) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]
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NDC 52183-220-25, 52183-220-90
Set ID 92e69995-3eeb-4810-9639-c0246bacc7ac
Category HUMAN OTC DRUG LABEL
Packager Prestige Brands Holdings, Inc.
Generic Name
Product Class
Product Number
Application Number PART356
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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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