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
  • Marketing Status: OTC monograph not final

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 April 2, 2018

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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°-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 NOT FINALpart35606/13/2017
    Labeler - Prestige Brands Holdings, Inc. (159655021)
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