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
  • 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 September 14, 2018

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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 NOT FINALpart35606/15/2018
    Labeler - Prestige Brands Holdings, Inc. (159655021)
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