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NDC 52183-0227-25 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	52183-0227
Product ID	52183-227_ee53bd6a-ffb8-4a8a-bf69-eab87daa0a03
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	2024-12-31

Package

Package Images

NDC 52183-0227-25 (52183022725)

Pricing Information	N/A
NDC Package Code	52183-227-25
Billing NDC	52183022725
Package	25 LOZENGE in 1 BAG (52183-227-25)
Marketing Start Date	2018-06-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d0213cb3-ec8e-40cc-82c9-694032f0490f 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.

PRINCIPAL 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:52183-227
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:52183-227-25	25 in 1 BAG; Type 0: Not a Combination Product	06/15/2018

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

Labeler - Prestige Brands Holdings, Inc. (159655021)

Revised: 9/2018

Document Id: ee53bd6a-ffb8-4a8a-bf69-eab87daa0a03

Set id: d0213cb3-ec8e-40cc-82c9-694032f0490f

Version: 1

Effective Time: 20180914