NDC 0113-0416 Good Sense Aspirin
Aspirin Tablet, Film Coated Oral

Product Information

Product Code0113-0416
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.
Good Sense 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, 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.
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.
L. Perrigo Company
Labeler Code0113
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.
04-15-1991
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.
12-31-2022
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

Usage Information


Product Characteristics

Color(s)WHITE (C48325)
ShapeROUND (C48348)
Size(s)14 MM
Imprint(s)ASPIRIN;L
Score1

Product Packages

NDC 0113-0416-78

Package Description: 100 TABLET, FILM COATED in 1 BOTTLE

Price per Unit: $0.01099 per EA

NDC 0113-0416-87

Package Description: 300 TABLET, FILM COATED in 1 BOTTLE

Price per Unit: $0.01075 per EA

NDC 0113-0416-90

Package Description: 500 TABLET, FILM COATED in 1 BOTTLE

Price per Unit: $0.01099 per EA

Product Details

Good Sense Aspirin is a human over the counter drug product labeled by L. Perrigo Company. The generic name of Good Sense Aspirin is aspirin. The product's dosage form is tablet, film coated and is administered via oral form.


What are Good Sense Aspirin Active Ingredients?

The following is the list of active ingredients in this product. 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.


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 code indicates a single concept unique identifier (RXCUI) is associated with this product:


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.

  • CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
  • TRIACETIN (UNII: XHX3C3X673)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • TALC (UNII: 7SEV7J4R1U)
  • STARCH, CORN (UNII: O8232NY3SJ)


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.

Patient Education

Aspirin

Aspirin is pronounced as (as' pir in)

Why is aspirin medication prescribed?
Prescription aspirin is used to relieve the symptoms of rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), osteoarthritis (arthritis caused ...
[Read More]

* Please review the disclaimer below.

Good Sense Aspirin Labeling and Warnings

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.

Table of Contents



Active Ingredient (In Each Tablet)



Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug


Purposes



Pain reliever/fever reducer


Uses



  • •temporarily relieves
  • •headache
  • •muscle pain
  • •toothache
  • •menstrual pain
  • •pain and fever of colds
  • •minor pain of arthritis

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:

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

Do Not Use



if you have ever had an allergic reaction to any other pain reliever/fever reducer


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

Ask A Doctor Or Pharmacist Before Use If You Are



taking a prescription drug for

  • •diabetes
  • •gout
  • •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 for more than 10 days
  • •fever lasts for more than 3 days
  • •ringing in the ears or loss of hearing occurs
  • •redness or swelling is present
  • •new symptoms occur
  • These 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 right away. (1-800-222-1222)


Directions



  • •drink a full glass of water with each dose
  • •adults 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
  • •children under 12 years: consult a doctor

Inactive Ingredients



corn starch, dibasic calcium phosphate dihydrate, hypromellose, talc, triacetin


Questions?



1-800-719-9260


Principal Display Panel



For Adults

Safe Pain Relief Plus Lifesaving Benefits**

Aspirin

Pain Reliever/Fever Reducer (NSAID)

**Aspirin is not appropriate for everyone, so be sure to talk to your doctor before you begin an aspirin regimen

Compare to active ingredient of Bayer® Aspirin

100 Coated Tablets – 325 mg


* Please review the disclaimer below.