LUDENS SUGAR FREE WILD CHERRY THROAT- pectin lozenge

LUDENS SUGAR FREE WILD CHERRY THROAT by

Drug Labeling and Warnings

LUDENS SUGAR FREE WILD CHERRY THROAT 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

Purpose

Oral Demulcent

Uses

For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat

Warnings

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

• sore mouth does not improve in 7 days
  
• irritation, pain or redness persists or worsens

Keep out of reach of children. 

Directions

• 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

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

Inactive ingredients

acesulfame potassium, citric acid, FD&C blue no.2, FD&C red no. 40, hydrogenated starch hydrolysate, isomalt, malic acid, soybean oil,water

Questions?

1-866-583-3677 Ludens.com

PRINCIPAL DISPLAY PANEL

Sugar Free
LUDEN’S® 
Wild Cherry
25 Throat Drops

INGREDIENTS AND APPEARANCE

LUDENS SUGAR FREE WILD CHERRY THROAT 
pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52183-249
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
ISOMALT (UNII: S870P55O2W)
MALIC ACID (UNII: 817L1N4CKP)
SOYBEAN OIL (UNII: 241ATL177A)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	LUDENS
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52183-249-18	18 in 1 BAG; Type 0: Not a Combination Product	07/12/2010
2	NDC: 52183-249-25	25 in 1 BAG; Type 0: Not a Combination Product	07/12/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	07/12/2010

Labeler - Prestige Brands Holdings, Inc. (159655021)

Establishment
Name	Address	ID/FEI	Business Operations
BestSweet Inc.		002149136	MANUFACTURE(52183-249)