Ludens

Manufacturer: Prestige Brands Holdings, Inc.
Effective date: 2024-10-25
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-01 20:50:38

Label at a glance#

ProductLudens Honey and Berry

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

Contacts and useful links#

PhoneLabel contact1-866-583-3677

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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
Honey & Berry
25 Throat Count

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

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Ludens Honey and Berry
pectin
CARAMEL
CITRIC ACID MONOHYDRATE
CORN SYRUP
FD&C BLUE NO. 1
FD&C RED NO. 40
HONEY
SODIUM ACETATE
SODIUM CHLORIDE
SOYBEAN OIL
SUCROSE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52183-212	52183-212-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PECTIN	89NA02M4RX	ACTIB
CARAMEL	T9D99G2B1R	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
CORN SYRUP	9G5L16BK6N	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
HONEY	Y9H1V576FH	IACT
SODIUM ACETATE	4550K0SC9B	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SOYBEAN OIL	241ATL177A	IACT
SUCROSE	C151H8M554	IACT
WATER	059QF0KO0R	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
8effd4f8-d2f0-4374-8371-59e99f51b96f			0aa3d6db-e885-4b82-b309-28f188d12806	2025-01-17	Warnings	Exact identifier spl set id: 0aa3d6db-e885-4b82-b309-28f188d12806

Reported adverse events (FAERS/openFDA)#

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