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NDC 52183-0225-25 Ludens 2.5; 2.8 mg/1; mg/1 Details

Ludens 2.5; 2.8 mg/1; mg/1

Ludens is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by Prestige Brands Holdings, Inc.. The primary component is MENTHOL; PECTIN.

Product Information

NDC	52183-0225
Product ID	52183-225_e27dac46-31e8-4925-940c-1eef27b16771
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Ludens
Proprietary Name Suffix	Dual Relief
Non-Proprietary Name	pectin and menthol
Product Type	HUMAN OTC DRUG
Dosage Form	LOZENGE
Route	ORAL
Active Ingredient Strength	2.5; 2.8
Active Ingredient Units	mg/1; mg/1
Substance Name	MENTHOL; PECTIN
Labeler Name	Prestige Brands Holdings, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	n/a

Package

Package Images

NDC 52183-0225-25 (52183022525)

Pricing Information	N/A
NDC Package Code	52183-225-25
Billing NDC	52183022525
Package	25 LOZENGE in 1 BAG (52183-225-25)
Marketing Start Date	2018-06-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4655aa98-4532-4a70-9ae6-693f4c312b41 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each drop)

Pectin 2.8 mg

Menthol 2.5 mg

Purpose

Oral demulcent

Cough suppressant

Uses

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

Warnings

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

■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

■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

Directions

■ 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

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

Inactive ingredients

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

Questions?

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 -

Luden’s®

Cough Suppressant/Oral Demulcent

DUAL RELIEF

Wild Cherry

25 Cough Drops

INGREDIENTS AND APPEARANCE

LUDENS DUAL RELIEF

pectin and menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-225
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PECTIN (UNII: 89NA02M4RX) (PECTIN - UNII:89NA02M4RX)	PECTIN	2.8 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.5 mg

Ingredient Name	Strength
Inactive Ingredients
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM ACETATE (UNII: 4550K0SC9B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SOYBEAN OIL (UNII: 241ATL177A)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	22mm
Flavor	CHERRY (wild cherry)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52183-225-25	25 in 1 BAG; Type 0: Not a Combination Product	06/15/2018	09/30/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	06/15/2018	09/30/2023

Labeler - Prestige Brands Holdings, Inc. (159655021)

Revised: 7/2020

Document Id: e27dac46-31e8-4925-940c-1eef27b16771

Set id: 4655aa98-4532-4a70-9ae6-693f4c312b41

Version: 2

Effective Time: 20200702