LUDENS KIWI-STRAWBERRY- pectin lozenge

Ludens Kiwi-Strawberry by

Drug Labeling and Warnings

Ludens Kiwi-Strawberry 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 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

INGREDIENTS AND APPEARANCE

LUDENS KIWI-STRAWBERRY 
pectin lozenge

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

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

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

Labeler - Prestige Brands Holdings, Inc. (159655021)