LUDENS SUGAR FREE WILD CHERRY THROAT (PECTIN) LOZENGE [BLACKSMITH BRANDS, INC.]

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LUDENS SUGAR FREE WILD CHERRY THROAT (PECTIN) LOZENGE [BLACKSMITH BRANDS, INC.]
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NDC 52183-249-25
Set ID 274fc80c-e5b2-41c7-a119-287d6e8a2258
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 20-25ºC (68-77ºF) in a dry place
  • Inactive ingredients

    acesulfame potassium, citric acid, FD&C blue no.2, FD&C red no. 40, hydrogenated starch hydrolysate, isomalt, malic acid, soybean oil,water

  • Questions or comments?

    call 1-866-583-3677 Ludens.com

  • PRINCIPAL DISPLAY PANEL

    Sugar Free
    LUDEN’S    ® WILD CHERRY
    25 Drops


    Sugar Free LUDEN’S® WILD CHERRY 25 Drops


  • INGREDIENTS AND APPEARANCE
    LUDENS SUGAR FREE WILD CHERRY THROAT 
    pectin lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-249
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN2.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)  
    ISOMALT (UNII: S870P55O2W)  
    MALIC ACID (UNII: 817L1N4CKP)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize22mm
    FlavorImprint Code LUDENS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52183-249-1818 in 1 BAG; Type 0: Not a Combination Product07/12/2010
    2NDC:52183-249-2525 in 1 BAG; Type 0: Not a Combination Product07/12/2010
    3NDC:52183-249-7575 in 1 BAG; Type 0: Not a Combination Product07/12/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35607/12/2010
    Labeler - Prestige Brands Holdings, Inc. (159655021)
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