Ludens Assorted Flavors

Manufacturer
Prestige Brands Holdings, Inc.
Effective date
2024-10-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:49:20

Label at a glance#

ProductLudens Assorted Flavors
Active ingredientPECTIN
Label structure10 sections

Indications and uses

For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Dosage and administration

• 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each drop)

OTC - ACTIVE INGREDIENT SECTION

Pectin 2.8 mg

Purpose

OTC - PURPOSE SECTION

Oral demulcent

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Warnings

WARNINGS SECTION

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

OTC - STOP USE SECTION

• sore mouth does not improve in 7 days

• irritation, pain or redness persists or worsens

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

 1-866-583-3677 Ludens.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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 DropsPRINCIPAL DISPLAY PANEL Luden’s Pectin Lozenge/ Oral Demulcent Assorted flavors Wild Cherry • Watermelon • Honey & Berry 90 Throat Drops

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52183-217LUDENS ASSORTED FLAVORS (PECTIN) LOZENGE [PRESTIGE BRANDS HOLDINGS, INC.]3Legacy NDC20241116_60d6da81-e128-4a9b-88de-39c48511196f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52183-21752183-217-90

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0323c306-f640-44b7-889a-3cba397e78c560d6da81-e128-4a9b-88de-39c48511196f2026-05-12WarningsExact identifier
spl set id: 60d6da81-e128-4a9b-88de-39c48511196f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.