LUDENS HONEY LEMON- pectin 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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Luden Honey Lemon

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

Other information

Inactive ingredients

ascorbic acid, citric acid, corn syrup, FD&C yellow no. 5, honey, lemon oil, sodium acetate, sodium chloride, sucrose, water

Questions?

1-866-583-3677  Ludens.com

PRINCIPAL DISPLAY PANEL

Luden’s ® 

Honey Lemon

Pectin lozenge/ oral demulcent

25 Throat Drops

Luden’s ® 

Honey Lemon

Pectin lozenge/ oral demulcent      

90 Throat Drops

PRINCIPAL DISPLAY PANEL
Luden’s ® 
Honey Lemon
Pectin lozenge/ oral demulcent 

25 Throat Drops 

Luden’s ® 
Honey Lemon
Pectin lozenge/ oral demulcent 	

90 Throat Drops

LUDENS HONEY LEMON 
pectin lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-220
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 YELLOW NO. 5 (UNII: I753WB2F1M)  
HONEY (UNII: Y9H1V576FH)  
LEMON OIL (UNII: I9GRO824LL)  
SODIUM ACETATE (UNII: 4550K0SC9B)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorYELLOWScoreno score
ShapeOVALSize23mm
FlavorLEMON, HONEYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52183-220-2525 in 1 BAG; Type 0: Not a Combination Product02/01/2018
2NDC:52183-220-9090 in 1 BAG; Type 0: Not a Combination Product02/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35602/01/2018
Labeler - Prestige Brands Holdings, Inc. (159655021)

Revised: 2/2019
Document Id: ee98e940-2bad-4bf7-a431-19ec0d4e71c3
Set id: 92e69995-3eeb-4810-9639-c0246bacc7ac
Version: 1
Effective Time: 20190225
 
Prestige Brands Holdings, Inc.