LUDENS KIWI-STRAWBERRY- pectin lozenge
Prestige Brands Holdings, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Ludens Kiwi Strawberry

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 20º-25ºC (68º-77ºF) in a dry place
contains FD&C yellow no. 5 (tartrazine) as a color additive

Inactive ingredients

ascorbic acid, citric acid, corn syrup, corn starch, FD&C blue no. 1, FD&C yellow no. 5, flavors, malic acid, soybean oil, sucrose, water

Questions?

1-866-583-3677 Ludens.com

PRINCIPAL DISPLAY PANEL

LUDEN’S
Kiwi-Strawberry
Pectin Lozenge/ Oral Demulcent
20 Moisture Drops

Principle display panel:

LUDEN’S
Kiwi-Strawberry
Pectin Lozenge/ Oral Demulcent
20 Moisture Drops

LUDENS KIWI-STRAWBERRY
pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-205
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
STARCH, CORN (UNII: O8232NY3SJ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
MALIC ACID (UNII: 817L1N4CKP)
SOYBEAN OIL (UNII: 241ATL177A)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	GREEN (pale green)	Score	no score
Shape	OVAL	Size	23mm
Flavor	STRAWBERRY (Kiwi-Strawberry)	Imprint Code	LUDENS
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52183-205-20	20 in 1 BAG; Type 0: Not a Combination Product	07/02/2012	05/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	07/02/2012	05/31/2021

Labeler - Prestige Brands Holdings, Inc. (159655021)

Revised: 7/2020

Document Id: db3a062d-41f4-40b1-8706-aa1d9694e61d

Set id: fa8efdf5-6441-43d8-8a32-1c210646b1f2

Version: 2

Effective Time: 20200703

Prestige Brands Holdings, Inc.