LUDENS ASSORTED FLAVORS- 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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Ludens Assorted Flavors

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

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)

Revised: 4/2018
Document Id: 973b7e0f-910d-440d-aadc-3e4f5b795c11
Set id: 60d6da81-e128-4a9b-88de-39c48511196f
Version: 2
Effective Time: 20180402
 
Prestige Brands Holdings, Inc.