NDC 53041-285 Guardian Loratadine

Loratadine

NDC Product Code 53041-285

NDC Code: 53041-285

Proprietary Name: Guardian Loratadine What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Loratadine What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
6 MM
Imprint(s):
L
Score: 1

NDC Code Structure

  • 53041 - Guardian Drug Company
    • 53041-285 - Guardian Loratadine

NDC 53041-285-21

Package Description: 1000 TABLET in 1 BOTTLE

NDC Product Information

Guardian Loratadine with NDC 53041-285 is a a human over the counter drug product labeled by Guardian Drug Company. The generic name of Guardian Loratadine is loratadine. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Guardian Drug Company

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Guardian Loratadine Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • LORATADINE 10 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Guardian Drug Company
Labeler Code: 53041
FDA Application Number: ANDA207569 What is the FDA Application Number?
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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 07-22-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Loratadine

Loratadine is pronounced as (lor at' a deen)

Why is loratadine medication prescribed?
Loratadine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and other allergies. These symptoms include ...
[Read More]

* Please review the disclaimer below.

Guardian Loratadine Product Label Images

Guardian Loratadine Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Tablet)

Loratadine USP, 10mg

Purpose

Antihistamine

Use(S)

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny nosesneezingitchy, watery eyesitching of the nose or throat

Warnings

.

Do Not Use

If you have ever had an allergic reaction to this product or any of its ingredients.

Ask A Doctor Before Use If You Have

Liver or kidney disease. Your doctor should determine if you need a different dose.

When Using This Product

Do not take more than directed. Taking more than directed may cause drowsiness.

Stop Use And Ask Doctor If

An allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breastfeeding,

Ask a health professional before use.

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours  children under 6 years of age ask a doctor consumers with liver or kidney disease  ask a doctor

Other Information

  • Store at 20o to 25oC (68o to 77oF) [See USP Controlled Room Temperature]Protect from excessive moisture SAFETY SEALED: DO NOT USE IF THE IMPRINTED BOTTLE SEAL WITH "SEALED FOR YOUR PROTECTION" IS OPEN OR TORN

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate

* Please review the disclaimer below.

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