Ludens Assorted Flavors: Package Insert and Label Information

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.

Drug Facts

A ctive 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
(click image for full-size original)

LUDENS ASSORTED FLAVORS
pectin lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52183-217
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PECTIN (PECTIN) PECTIN 2.8 mg
Inactive Ingredients
Ingredient Name Strength
ASCORBIC ACID
CITRIC ACID MONOHYDRATE
CORN SYRUP
FD&C BLUE NO. 2
FD&C RED NO. 40
MALIC ACID
SODIUM ACETATE
SODIUM CHLORIDE
SOYBEAN OIL
SUCROSE
WATER
CARAMEL
FD&C BLUE NO. 1
HONEY
Product Characteristics
Color RED, YELLOW Score no score
Shape OVAL Size 23mm
Flavor FRUIT (Wild cherry, watermelon, honey & berry) Imprint Code LUDENS
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52183-217-90 90 LOZENGE in 1 BAG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part356 06/13/2017
Labeler — Prestige Brands Holdings, Inc. (159655021)

Revised: 04/2018 Prestige Brands Holdings, Inc.

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