LUDENS DUAL RELIEF- pectin and menthol lozenge

Ludens by

Drug Labeling and Warnings

Ludens by is a Otc medication manufactured, distributed, or labeled by Prestige Brands Holdings, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52183-227-25	25 in 1 BAG; Type 0: Not a Combination Product	06/15/2018

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

Labeler - Prestige Brands Holdings, Inc. (159655021)