Label: LUDENS ASSORTED FLAVORS- pectin lozenge

  • NDC Code(s): 52183-217-90
  • Packager: Prestige Brands Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2024

If you are a consumer or patient please visit this version.

  • 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°-25°C (68°-77°F) in a dry place

  • Inactive ingredients

    Wild Cherry: ascorbic acid, citric acid, corn syrup, FD&C blue no. 2, FD&C red no. 40, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water

    Watermelon: ascorbic acid, citric acid, corn syrup, FD&C red no. 40, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water

    Honey & Berry: 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
    Assorted flavors
    Wild Cherry • Watermelon • Honey & Berry
    90 Throat Drops

    PRINCIPAL DISPLAY PANEL
Luden’s
Pectin Lozenge/ Oral Demulcent
Assorted flavors 
Wild Cherry • Watermelon • Honey & Berry 
90 Throat Drops

  • INGREDIENTS AND APPEARANCE
    LUDENS ASSORTED FLAVORS 
    pectin lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-217
    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 BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MALIC ACID (UNII: 817L1N4CKP)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    CARAMEL (UNII: T9D99G2B1R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HONEY (UNII: Y9H1V576FH)  
    Product Characteristics
    Colorred, yellowScoreno score
    ShapeOVALSize23mm
    FlavorFRUIT (Wild cherry, watermelon, honey & berry) Imprint Code LUDENS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52183-217-9090 in 1 BAG; Type 0: Not a Combination Product06/13/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02206/13/2017
    Labeler - Prestige Brands Holdings, Inc. (159655021)