FDA.reportPublic FDA data

Ludens

Manufacturer
Prestige Brands Holdings, Inc.
Effective date
2020-07-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:23:22

Label at a glance#

ProductLudens Dual Relief
Active ingredientPECTIN, MENTHOL
Label structure10 sections

Indications and uses

temporarily relieves:   ■minor discomfort and protection of irritated areas in sore mouth and sore throat ■ cough associated with a cold or inhaled irritants.

Dosage and administration

■  adults and children 3 years of age and older : allow two drops 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

Menthol 2.5 mg

Purpose

OTC - PURPOSE SECTION

Oral demulcent

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves: ■minor discomfort and protection of irritated areas in sore mouth and sore throat ■ cough associated with a cold or inhaled irritants.

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, nausea, or vomiting, consult a doctor promptly. These may be serious.  

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

■cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if

OTC - STOP USE SECTION

■sore mouth symptoms do not improve in 7 days

■cough lasts more than 7 days, tends to recur, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

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 two drops 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 

SPL UNCLASSIFIED SECTION

store at 20º-25ºC (68º-77ºF) in a dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn syrup, FD&C blue no. 2, FD&C red no. 40, flavor, propylene glycol, sodium acetate, sodium chloride, soybean oil, sucrose, water

Questions?

OTC - QUESTIONS SECTION

1-866-583-3677  Ludens.com

Distributed by Medtech Products Inc.
Tarrytown, NY 10591
A Prestige Brands Company
©2018 Trade dress is owned by Medtech Products Inc. All rights reserved.

PRINCIPLE DISPLAY PANEL -

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Luden’s®

Cough Suppressant/Oral Demulcent

DUAL RELIEF

Wild Cherry

25 Cough Drops

Luden’s® Cough Suppressant/Oral Demulcent DUAL RELIEF Wild Cherry 25 Cough DropsLuden’s® Cough Suppressant/Oral Demulcent DUAL RELIEF Wild Cherry 25 Cough Drops

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52183-225-252020-07-01C16284748780-19d75b9d0-9013-f424-e053-dadaa90a57ceLudens Dual Relief Wild Cherry - 52183-225-25
52183-225-252020-01-31C16284748780-19d75b9d0-9013-f424-e053-dadaa90a57ceLudens Dual Relief Wild Cherry - 52183-225-25

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52183-22552183-225-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
PECTIN89NA02M4RXACTIB
MENTHOLL7T10EIP3AACTIB
CORN SYRUP9G5L16BK6NIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
FD&C RED NO. 40WZB9127XOAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM ACETATE4550K0SC9BIACT
SODIUM CHLORIDE451W47IQ8XIACT
SOYBEAN OIL241ATL177AIACT
SUCROSEC151H8M554IACT
WATER059QF0KO0RIACT

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
e27dac46-31e8-4925-940c-1eef27b167714655aa98-4532-4a70-9ae6-693f4c312b412020-07-02WarningsExact identifier
spl id: e27dac46-31e8-4925-940c-1eef27b16771
spl set id: 4655aa98-4532-4a70-9ae6-693f4c312b41

Reported adverse events (FAERS/openFDA)#

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