LUDENS HONEY LEMON- pectin lozenge

Ludens Honey Lemon by

Drug Labeling and Warnings

Ludens Honey Lemon 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, FD&C yellow no. 5, honey, lemon oil, sodium acetate, sodium chloride, sucrose, water

Questions?

1-866-583-3677  Ludens.com

PRINCIPAL DISPLAY PANEL

Luden’s ® 

Honey Lemon

Pectin lozenge/ oral demulcent

25 Throat Drops

Luden’s ® 

Honey Lemon

Pectin lozenge/ oral demulcent      

90 Throat Drops

INGREDIENTS AND APPEARANCE

LUDENS HONEY LEMON 
pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52183-220
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)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
HONEY (UNII: Y9H1V576FH)
LEMON OIL (UNII: I9GRO824LL)
SODIUM ACETATE (UNII: 4550K0SC9B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	YELLOW	Score	no score
Shape	OVAL	Size	23mm
Flavor	LEMON, HONEY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52183-220-25	25 in 1 BAG; Type 0: Not a Combination Product	02/01/2018
2	NDC: 52183-220-90	90 in 1 BAG; Type 0: Not a Combination Product	02/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	02/01/2018

Labeler - Prestige Brands Holdings, Inc. (159655021)