NDC 53943-152 Adult Chewable Aspirin
Aspirin Tablet, Chewable Oral

Product Information

What is NDC 53943-152?

The NDC code 53943-152 is assigned by the FDA to the product Adult Chewable Aspirin which is a human over the counter drug product labeled by Discount Drug Mart. The generic name of Adult Chewable Aspirin is aspirin. The product's dosage form is tablet, chewable and is administered via oral form. The product is distributed in a single package with assigned NDC code 53943-152-01 1 bottle, plastic in 1 carton / 36 tablet, chewable in 1 bottle, plastic. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code53943-152
Proprietary Name 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.		Adult Chewable Aspirin
Non-Proprietary Name 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.		Aspirin
Product Type 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.		Human Otc Drug
Dosage FormTablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
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.		Discount Drug Mart
Labeler Code53943
FDA Application Number 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.		part343
Marketing Category 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.		OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		09-24-2021
Listing Expiration Date 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.		12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

What are the uses for Adult Chewable Aspirin?


Product Characteristics

Color(s)ORANGE (C48331)
ShapeROUND (C48348)
Size(s)8 MM
Imprint(s)AP;009
Score1
Flavor(s)ORANGE (C73406)

Product Packages

NDC Code 53943-152-01

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 36 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

Product Details

What are Adult Chewable Aspirin Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ASPIRIN 81 mg/1 - The prototypical analgesic used in the treatment of mild to moderate pain. It has anti-inflammatory and antipyretic properties and acts as an inhibitor of cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins. Aspirin also inhibits platelet aggregation and is used in the prevention of arterial and venous thrombosis. (From Martindale, The Extra Pharmacopoeia, 30th ed, p5)

Adult Chewable Aspirin Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Adult Chewable Aspirin Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Adult Chewable Aspirin Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Other



Drug Facts


Active Ingredient (In Each Tablet)



Aspirin 81 mg (NSAID)*

* nonsteroidal anti-inflammatory drug


Purpose



Pain reliever


Uses



  • temporarily relieves minor aches and pains
  • ask your doctor about other uses for this product

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:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Stomach Bleeding Warning



This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Otc - Do Not Use



Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

Ask A Doctor Before Use If



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

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking a prescription drug for:

  • gout
  • diabetes
  • arthritis

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 faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • ringing in the ears or a loss of hearing occurs

      • These could be signs of a serious condition.


Otc - Pregnancy Or Breast Feeding



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.


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 (1-800-222-1222).


Directions



  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
  • children under 12 years: do not use unless directed by a doctor

Other Information



  • store between 20°-25°C (68°-77°F) in a dry place
  • retain carton for complete product information and warnings

Inactive Ingredients



corn starch, FD&C yellow #6 aluminum lake, flavor, magnesium stearate, silicon dioxide, sucrose


Questions Or Comments?



1-844-705-4384


Principal Display Panel



Discount Drug Mart Food Market

NDC 53943-152-01

†Compare to the active ingredient in St. Joseph® Low Dose Chewable Aspirin

Low Dose

Adult Chewable Aspirin

Pain Reliever (NSAID)

Actual Size

ADULT ASPIRIN REGIMEN**

ORANGE FLAVORED

Talk to your doctor or other healthcare provider before using this product for your heart.

36 TABLETS

81 MG EACH

image description - F1152B01DDM R0

image description - F1152B01DDM R0


* Please review the disclaimer below.