Label: LUDENS SUGAR FREE WILD CHERRY THROAT- pectin lozenge

  • NDC Code(s): 52183-249-18, 52183-249-25, 52183-249-75
  • Packager: Prestige Brands Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 December 25, 2020

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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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