NDC 50844-254 Coated Aspirin

Aspirin

NDC Product Code 50844-254

NDC Code: 50844-254

Proprietary Name: Coated Aspirin 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: Aspirin 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):
10 MM
Imprint(s):
44;157;ASPIRIN
Score: 1

NDC Code Structure

  • 50844 - L.n.k. International, Inc.
    • 50844-254 - Coated Aspirin

NDC 50844-254-12

Package Description: 1 BOTTLE in 1 CARTON > 100 TABLET, FILM COATED in 1 BOTTLE

NDC Product Information

Coated Aspirin with NDC 50844-254 is a a human over the counter drug product labeled by L.n.k. International, Inc.. The generic name of Coated Aspirin is aspirin. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: L.n.k. International, Inc.

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.

Coated Aspirin 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.

  • ASPIRIN 325 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.

  • STARCH, CORN (UNII: O8232NY3SJ)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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: L.n.k. International, Inc.
Labeler Code: 50844
FDA Application Number: part343 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: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 07-15-2019 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.

Coated Aspirin Product Label Images

Coated Aspirin 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)

Aspirin 325 mg (NSAID)**nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves:minor pain of arthritisheadache
  • Muscle painmenstrual pain
  • Toothachepain and fever of colds

Warnings

  • Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.Allergy alert: Aspirin may cause a severe allergic reaction, which may include:facial swellingshockhivesasthma (wheezing)Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if youare age 60 or oldertake a blood thinning (anticoagulant) or steroid drughave 3 or more alcoholic drinks every day while using this producthave had stomach ulcers or bleeding problemtake more or for a longer time than directedtake other drugs containing prescription and nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]

Do Not Use

  • If you are allergic to aspirin or any other pain reliever/fever reducerif you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If

  • You are taking a diureticstomach bleeding warning applies to youyou have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou have asthma

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking a prescription drug forgoutdiabetesarthritis

Stop Use And Ask A Doctor If

  • An allergic reaction occurs. Seek medical help right away.you experience any of the following signs of stomach bleeding:feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betterringing in the ears or a loss of hearing occurspain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurThese could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.  It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • Drink a full glass of water with each doseadults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours not to exceed 12 tablets in 24 hours unless directed by a doctorchildren under 12 years: do not use unless directed by a doctor

Other Information

  • Store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)use by expiration date on package

Inactive Ingredients

Corn starch, hypromellose, polyethylene glycol, propylene glycol

* Please review the disclaimer below.

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