NDC 47682-913 Medi First Plus Allergy Relief

Loratadine

NDC Product Code 47682-913

NDC Code: 47682-913

Proprietary Name: Medi First Plus Allergy Relief 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.

NDC Code Structure

  • 47682 - Unifirst First Aid Corporation
    • 47682-913 - Medi First Plus Allergy Relief

NDC 47682-913-33

Package Description: 100 PACKET in 1 BOX > 1 TABLET, FILM COATED in 1 PACKET

NDC 47682-913-46

Package Description: 1 TABLET, FILM COATED in 1 PACKET

NDC Product Information

Medi First Plus Allergy Relief with NDC 47682-913 is a a human over the counter drug product labeled by Unifirst First Aid Corporation. The generic name of Medi First Plus Allergy Relief is loratadine. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Unifirst First Aid Corporation

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

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.

Medi First Plus Allergy Relief 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

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: Unifirst First Aid Corporation
Labeler Code: 47682
FDA Application Number: ANDA076134 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: 04-23-2019 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.

Medi First Plus Allergy Relief Product Label Images

Medi First Plus Allergy Relief 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

Other

Drug Facts

Adults and children(12 years and older): 1 tablet daily; not more than 1 tablet in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

Consumers with liver or kidney disease Ask a doctor before using.

Active Ingredient (In Each Tablet)

Loratadine 10 mg

Purpose

Antihistamine

Uses

  • Temporarily relieves these symptoms due to hay fever or other upper respiratory allergiesrunny noseitchy, watery eyessneezingitching of the nose or throat

Otc - Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Otc - Ask Doctor

Ask a doctor before use if you have liver or kidney disease.
Your doctor should determine if you need a different dose.

Otc - When Using

When using this product do not take more than directed.






Taking more than directed may cause drowsiness.

Stop Use And Ask A Doctor If

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

Other Information

  • Tamper evident sealed packetsdo not use any opened or torn packetsstore between 68º and 77ºF (20º and 25ºC )protect from excessive moisture

Inactive Ingredients

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch.

* Please review the disclaimer below.

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