LUDENS HONEY AND BERRY- 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 Honey and Berry

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 20-25C (68-77F) in a dry place

Inactive ingredients

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
Honey & Berry
25 Throat Count

Luden’s
Pectin lozenge/ Oral demulcent
Honey & Berry 
25 Throat Count

LUDENS  HONEY AND BERRY
pectin lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-212
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX) PECTIN2.8 mg
Inactive Ingredients
Ingredient NameStrength
CARAMEL (UNII: T9D99G2B1R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CORN SYRUP (UNII: 9G5L16BK6N)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HONEY (UNII: Y9H1V576FH)  
SODIUM ACETATE (UNII: 4550K0SC9B)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SOYBEAN OIL (UNII: 241ATL177A)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorYELLOW, PURPLEScoreno score
ShapeCAPSULESize22mm
FlavorBLACKBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52183-212-2525 in 1 BAG; Type 0: Not a Combination Product07/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35607/01/2017
Labeler - Prestige Brands Holdings, Inc. (159655021)

Revised: 5/2017
Document Id: 220c0e48-cfca-4a78-83da-5b75432ceed6
Set id: 0aa3d6db-e885-4b82-b309-28f188d12806
Version: 1
Effective Time: 20170531
 
Prestige Brands Holdings, Inc.