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

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LUDENS HONEY AND BERRY (PECTIN) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]
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NDC 52183-212-25
Set ID 0aa3d6db-e885-4b82-b309-28f188d12806
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 20-25C (68-77F) in a dry place

  • Inactive ingredients

    caramel color, citric acid, corn syrup, FD&C blue no. 1, FD&C red no. 40, flavor, honey, sodium acetate, sodium chloride, soybean oil, sucrose, water

  • Questions?

    1-866-583-3677 Ludens.com

  • PRINCIPAL DISPLAY PANEL

    Luden’s

    Pectin lozenge/ Oral demulcent
    Honey & Berry
    25 Throat Count

    Luden’s Pectin lozenge/ Oral demulcent Honey & Berry 25 Throat Count

  • INGREDIENTS AND APPEARANCE
    LUDENS  HONEY AND BERRY
    pectin lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-212
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN2.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARAMEL (UNII: T9D99G2B1R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HONEY (UNII: Y9H1V576FH)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorYELLOW, PURPLEScoreno score
    ShapeCAPSULESize22mm
    FlavorBLACKBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52183-212-2525 in 1 BAG; Type 0: Not a Combination Product07/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35607/01/2017
    Labeler - Prestige Brands Holdings, Inc. (159655021)
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