LUDENS HONEY AND BERRY- pectin 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

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 20-25C (68-77F) in a dry place

Inactive ingredients

caramel color, citric acid, corn syrup, FD&C blue no. 1, FD&C red no. 40, flavor, honey, sodium acetate, sodium chloride, soybean oil, sucrose, water

Questions?

1-866-583-3677 Ludens.com

PRINCIPAL DISPLAY PANEL

Luden’s

Pectin lozenge/ Oral demulcent
Honey & Berry
25 Throat Count

INGREDIENTS AND APPEARANCE

LUDENS  HONEY AND BERRY
pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52183-212
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
CARAMEL (UNII: T9D99G2B1R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HONEY (UNII: Y9H1V576FH)
SODIUM ACETATE (UNII: 4550K0SC9B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SOYBEAN OIL (UNII: 241ATL177A)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	YELLOW, PURPLE	Score	no score
Shape	CAPSULE	Size	22mm
Flavor	BLACKBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52183-212-25	25 in 1 BAG; Type 0: Not a Combination Product	07/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	07/01/2017

Labeler - Prestige Brands Holdings, Inc. (159655021)