Label: LUDENS DUAL RELIEF- pectin and menthol lozenge

  • NDC Code(s): 52183-227-25
  • Packager: Prestige Brands Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each drop)

    Pectin 2.8 mg 

    Menthol 2.5 mg

  • Purpose

    Oral demulcent

    Cough suppressant

  • Uses

    temporarily relieves:

    • minor discomfort and protection of irritated areas in sore mouth and sore throat
    • cough associated with a cold or inhaled irritants.
  • Warnings

    Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. These may be serious.  

    Ask a doctor before use if you have

    • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
    • cough that occurs with too much phlegm (mucus)

    Stop use and ask a doctor if

    • sore mouth symptoms do not improve in 7 days
    • cough lasts more than 7 days, tends to recur, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

    Keep out of reach of children

  • Directions

    • adults and children 3 years of age and older: allow two drops 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 20º-25ºC (68º-77ºF) in a dry place

  • Inactive ingredients

    corn syrup, FD&C blue no. 2, FD&C red no. 40, flavor, propylene glycol, sodium acetate, sodium chloride, soybean oil, sucrose, water

  • Questions?

    1-866-583-3677  Ludens.com

    Distributed by Medtech Products Inc.
    Tarrytown, NY 10591
    A Prestige Brands Company
    ©2018 Trade dress is owned by Medtech Products Inc. All rights reserved.

  • PRINCIPAL DISPLAY PANEL

    Luden’s®

    Cough Suppressant/Oral Demulcent

    DUAL RELIEF

    Wild Cherry

    25 Cough Drops

    PRINCIPAL DISPLAY PANEL Luden’s® Cough Suppressant/Oral Demulcent DUAL RELIEF Wild Cherry 25 Cough Drops

  • INGREDIENTS AND APPEARANCE
    LUDENS  DUAL RELIEF
    pectin and menthol lozenge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-227
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN2.8 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize22mm
    FlavorCHERRY (Wild Cherry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52183-227-2525 in 1 BAG; Type 0: Not a Combination Product06/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02206/15/2018
    Labeler - Prestige Brands Holdings, Inc. (159655021)
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