LUDENS DUAL RELIEF- pectin and menthol lozenge 
Prestige Brands Holdings, Inc.

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.

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Ludens Dual Relief

Drug Facts

Active ingredient (in each drop)

Pectin 2.8 mg 

Menthol 2.5 mg

Purpose

Oral demulcent

Cough suppressant

Uses

temporarily relieves:

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

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

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)

Revised: 9/2018
Document Id: ee53bd6a-ffb8-4a8a-bf69-eab87daa0a03
Set id: d0213cb3-ec8e-40cc-82c9-694032f0490f
Version: 1
Effective Time: 20180914
 
Prestige Brands Holdings, Inc.