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  4. Ludens Strawberry Banana Throat Drops

Ludens Strawberry Banana Throat Drops

Pectin


Prestige Brands Holdings, Inc.
Human Otc Drug
NDC 52183-209
Ludens Strawberry Banana Throat Drops also known as Pectin is a human otc drug labeled by 'Prestige Brands Holdings, Inc.'. National Drug Code (NDC) number for Ludens Strawberry Banana Throat Drops is 52183-209. This drug is available in dosage form of Lozenge. The names of the active, medicinal ingredients in Ludens Strawberry Banana Throat Drops drug includes Pectin - 2.8 mg/1 . The currest status of Ludens Strawberry Banana Throat Drops drug is Active.

Drug Information:

Drug NDC: 52183-209
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Ludens Strawberry Banana Throat Drops
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Pectin
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Prestige Brands Holdings, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Lozenge
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:PECTIN - 2.8 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: OTC MONOGRAPH NOT FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 01 Jul, 2015
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 15 Jan, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: part356
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Prestige Brands Holdings, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:616469
637146
1044442
1044444
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:89NA02M4RX
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
52183-209-2525 LOZENGE in 1 BAG (52183-209-25)01 Jul, 2015N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.
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Ludens Strawberry Banana Throat Drops


Pectin

Lozenge
Prestige Brands Holdings, Inc.
NDC: 52183-209

Purpose:

Purpose oral demulcent

Purpose oral demulcent

Purpose oral demulcent

Purpose oral demulcent

Purpose oral demulcent

Purpose oral demulcent

Purpose oral demulcent

Purpose oral demulcent

Purpose oral demulcent

Purpose oral demulcent

Product Elements:

Ludens berry assortment throat drops pectin pectin pectin ascorbic acid citric acid monohydrate corn syrup fd&c blue no. 2 fd&c red no. 40 malic acid sodium acetate sodium chloride soybean oil sucrose fd&c blue no. 1 ludens ludens wild cherry throat drops pectin pectin pectin ascorbic acid citric acid monohydrate corn syrup fd&c blue no. 2 fd&c red no. 40 malic acid sodium acetate sodium chloride soybean oil sucrose ludens ludens wild cherry throat drops pectin pectin pectin ascorbic acid citric acid monohydrate corn syrup fd&c blue no. 2 fd&c red no. 40 malic acid sodium acetate sodium chloride soybean oil sucrose ludens strawberry banana throat drops pectin pectin pectin citric acid monohydrate corn syrup fd&c blue no. 2 fd&c red no. 40 fd&c yellow no. 6 malic acid sodium acetate sodium chloride soybean oil sucrose water strawberry banana strawberry banana ludens strawberry banana throat drops pectin pectin pectin citric acid monohydrate corn syrup fd&c blue no. 2 fd&c red no. 40 fd&c yellow no. 6 malic acid sodium acetate sodium chloride soybean oil sucrose water strawberry banana strawberry banana ludens green apple throat drops pectin pectin pectin citric acid monohydrate corn syrup fd&c blue no. 1 fd&c yellow no. 5 malic acid sodium acetate sucrose water green apple ludens blue raspberry throat drops pectin pectin pectin ascorbic acid citric acid monohydrate corn syrup fd&c blue no. 1 malic acid sodium acetate sodium chloride soybean oil sucrose water blue raspberry ludens ludens blue raspberry throat drops pectin pectin pectin ascorbic acid citric acid monohydrate corn syrup fd&c blue no. 1 malic acid sodium acetate sodium chloride soybean oil sucrose water blue raspberry ludens ludens watermelon throat drops pectin pectin pectin ascorbic acid citric acid monohydrate corn syrup fd&c red no. 40 malic acid sodium acetate sodium chloride soybean oil sucrose water light red ludens ludens watermelon throat drops pectin pectin pectin ascorbic acid citric acid monohydrate corn syrup fd&c red no. 40 malic acid sodium acetate sodium chloride soybean oil sucrose water ludens

Indications and Usage:

Uses for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Uses for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Uses for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Uses for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Uses for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Uses for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Uses for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat

Use s for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Uses for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Uses for temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.

Warnings:

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

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

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

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

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

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 .

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 .

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

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

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

Dosage and Administration:

Directions a dults 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

Directions a dults 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

Directions a dults 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

Directions a dults 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

Directions a dults 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

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

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

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

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

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

Stop Use:

Stop use and ask a doctor if sore mouth does not improve in 7 days irritation, pain or redness persists or worsens.

Stop use and ask a doctor if sore mouth does not improve in 7 days irritation, pain or redness persists or worsens.

Stop use and ask a doctor if sore mouth does not improve in 7 days irritation, pain or redness persists or worsens.

Stop use and ask a doctor if sore mouth does not improve in 7 days irritation, pain or redness persists or worsens.

Stop use and ask a doctor if sore mouth does not improve in 7 days irritation, pain or redness persists or worsens.

Stop use and ask a doctor if sore mouth does not improve in 7 days irritation, pain or redness persists or worsens

Stop use and ask a doctor if sore mouth does not improve in 7 days irritation, pain or redness persists or worsens

Stop use and ask a doctor if • sore mouth does not improve in 7 days • irritation, pain or redness persists or worsens

Stop use and ask a doctor if • sore mouth does not improve in 7 days • irritation, pain or redness persists or worsens

Stop use and ask a doctor if • sore mouth does not improve in 7 days • irritation, pain or redness persists or worsens

Package Label Principal Display Panel:

Principal display panel luden’s pectin lozenge/oral demulcent blue raspberry 25 throat drops luden’s pectin lozenge/oral demulcent blue raspberry 25 throat drops

Principal display panel luden’s pectin lozenge/oral demulcent blue raspberry 20 throat drops luden’s pectin lozenge/oral demulcent blue raspberry 20 throat drops

Principal display panel luden’s pectin lozenge/oral demulcent watermelon 25 throat drops luden’s pectin lozenge/oral demulcent watermelon 25 throat drops

Principal display panel luden’s pectin lozenge/oral demulcent watermelon 20 throat drops luden’s pectin lozenge/oral demulcent watermelon 20 throat drops

Principal display panel luden’s pectin lozenge/oral demulcent watermelon 90 throat drops principal display panel luden’s pectin lozenge/oral demulcent watermelon 90 throat drops

Principal display panel luden’s pectin lozenge/oral demulcent wild berry 30 drops luden’s pectin lozenge/oral demulcent wild berry 30 drops

Principal display panel luden’s pectin lozenge oral demulcent wild ch erry 14 drops luden’s pectin lozenge oral demulcent wild cherry 14 drops

Principal display panel luden’s pectin lozenge/ oral demulcent wild ch erry 30 drops luden’s pectin lozenge/oral demulcent wild cherry 30 drops

Principal display panel luden’s strawberry-banana pectin lozenge / oral demulcent 20 throat drops luden’s strawberry-banana pectin lozenge / oral demulcent 20 throat drops

Principal display panel luden’s strawberry-banana pectin lozenge / oral demulcent 25 throat drops luden’s strawberry-banana pectin lozenge / oral demulcent 25 throat drops

Principal display panel luden’s green apple pectin lozenge / oral demulcent 25 throat drops luden’s green apple pectin lozenge / oral demulcent 25 throat drops

Further Questions:

Questions? 1-866-583-3677 ludens.com

Questions? 1-866-583-3677 ludens.com

Questions? 1-866-583-3677 ludens.com

Questions? 1-866-583-3677 ludens.com

Questions? 1-866-583-3677 ludens.com

Questions or comments? call 1-866-583-3677 luden’s wild cherry throat drops drug facts

Questions or comments? call 1-866-583-3677 l uden's s trawberry banana throat drops drug facts

Questions? 1-866-583-3677 ludens.com l uden's s trawberry banana throat drops drug facts

Questions? 1-866-583-3677 ludens.com luden's green apple throat drops drug facts

Questions? 1-866-583-3677 ludens.com


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