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NDC 52183-0217-90 Ludens Assorted Flavors 2.8 mg/1 Details

Ludens Assorted Flavors 2.8 mg/1

Ludens Assorted Flavors 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	52183-0217
Product ID	52183-217_973b7e0f-910d-440d-aadc-3e4f5b795c11
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 Assorted Flavors
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 52183-0217-90 (52183021790)

Pricing Information	N/A
NDC Package Code	52183-217-90
Billing NDC	52183021790
Package	90 LOZENGE in 1 BAG (52183-217-90)
Marketing Start Date	2017-06-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 60d6da81-e128-4a9b-88de-39c48511196f 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 20°-25°C (68°-77°F) in a dry place

Inactive ingredients

Wild Cherry: ascorbic acid, citric acid, corn syrup, FD&C blue no. 2, FD&C red no. 40, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water

Watermelon: ascorbic acid, citric acid, corn syrup, FD&C red no. 40, flavors, malic acid, sodium acetate, sodium chloride, soybean oil, sucrose, water

Honey & Berry: 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

Assorted flavors

Wild Cherry • Watermelon • Honey & Berry

90 Throat Drops

INGREDIENTS AND APPEARANCE

LUDENS ASSORTED FLAVORS

pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-217
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 BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALIC ACID (UNII: 817L1N4CKP)
SODIUM ACETATE (UNII: 4550K0SC9B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SOYBEAN OIL (UNII: 241ATL177A)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)
CARAMEL (UNII: T9D99G2B1R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HONEY (UNII: Y9H1V576FH)

Product Characteristics
Color	RED, YELLOW	Score	no score
Shape	OVAL	Size	23mm
Flavor	FRUIT (Wild cherry, watermelon, honey & berry)	Imprint Code	LUDENS
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52183-217-90	90 in 1 BAG; Type 0: Not a Combination Product	06/13/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	06/13/2017

Labeler - Prestige Brands Holdings, Inc. (159655021)

Revised: 4/2018

Document Id: 973b7e0f-910d-440d-aadc-3e4f5b795c11

Set id: 60d6da81-e128-4a9b-88de-39c48511196f

Version: 2

Effective Time: 20180402