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NDC 52183-0220-25 Ludens Honey Lemon 2.8 mg/1 Details

Ludens Honey Lemon 2.8 mg/1

Ludens Honey Lemon is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by Prestige Brands Holdings, Inc.. The primary component is PECTIN.

Product Information

NDC	52183-0220
Product ID	52183-220_ee98e940-2bad-4bf7-a431-19ec0d4e71c3
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Ludens Honey Lemon
Proprietary Name Suffix	n/a
Non-Proprietary Name	pectin
Product Type	HUMAN OTC DRUG
Dosage Form	LOZENGE
Route	ORAL
Active Ingredient Strength	2.8
Active Ingredient Units	mg/1
Substance Name	PECTIN
Labeler Name	Prestige Brands Holdings, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part356
Listing Certified Through	2024-12-31

Package

Package Images

NDC 52183-0220-25 (52183022025)

Pricing Information	N/A
NDC Package Code	52183-220-25
Billing NDC	52183022025
Package	25 LOZENGE in 1 BAG (52183-220-25)
Marketing Start Date	2018-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 92e69995-3eeb-4810-9639-c0246bacc7ac Details

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

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)
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	02/01/2018

Labeler - Prestige Brands Holdings, Inc. (159655021)

Revised: 2/2019

Document Id: ee98e940-2bad-4bf7-a431-19ec0d4e71c3

Set id: 92e69995-3eeb-4810-9639-c0246bacc7ac

Version: 1

Effective Time: 20190225