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NDC 52183-0249-75 LUDENS SUGAR FREE WILD CHERRY THROAT 2.8 mg/1 Details

LUDENS SUGAR FREE WILD CHERRY THROAT 2.8 mg/1

LUDENS SUGAR FREE WILD CHERRY THROAT 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	52183-0249
Product ID	52183-249_96bdef6f-54dc-4cf2-a89f-85f2e53fc057
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 SUGAR FREE WILD CHERRY THROAT
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 52183-0249-75 (52183024975)

Pricing Information	N/A
NDC Package Code	52183-249-75
Billing NDC	52183024975
Package	75 LOZENGE in 1 BAG (52183-249-75)
Marketing Start Date	2010-07-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 274fc80c-e5b2-41c7-a119-287d6e8a2258 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 20-25ºC (68-77ºF) in a dry place

Inactive ingredients

acesulfame potassium, citric acid, FD&C blue no.2, FD&C red no. 40, hydrogenated starch hydrolysate, isomalt, malic acid, soybean oil,water

Questions or comments?

call 1-866-583-3677 Ludens.com

PRINCIPAL DISPLAY PANEL

Sugar Free

LUDEN’S® WILD CHERRY

25 Drops

INGREDIENTS AND APPEARANCE

LUDENS SUGAR FREE WILD CHERRY THROAT

pectin lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52183-249
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)
ISOMALT (UNII: S870P55O2W)
MALIC ACID (UNII: 817L1N4CKP)
SOYBEAN OIL (UNII: 241ATL177A)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	LUDENS
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52183-249-18	18 in 1 BAG; Type 0: Not a Combination Product	07/12/2010
2	NDC:52183-249-25	25 in 1 BAG; Type 0: Not a Combination Product	07/12/2010
3	NDC:52183-249-75	75 in 1 BAG; Type 0: Not a Combination Product	07/12/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part356	07/12/2010

Labeler - Prestige Brands Holdings, Inc. (159655021)

Revised: 12/2020

Document Id: 96bdef6f-54dc-4cf2-a89f-85f2e53fc057

Set id: 274fc80c-e5b2-41c7-a119-287d6e8a2258

Version: 6

Effective Time: 20201225