NDC 10135-689 Aspirin 81 Mg Enteric Coated

Aspirin

NDC Product Code 10135-689

NDC CODE: 10135-689

Proprietary Name: Aspirin 81 Mg Enteric Coated 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Aspirin is used to reduce fever and relieve mild to moderate pain from conditions such as muscle aches, toothaches, common cold, and headaches. It may also be used to reduce pain and swelling in conditions such as arthritis. Aspirin is known as a salicylate and a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking a certain natural substance in your body to reduce pain and swelling. Consult your doctor before treating a child younger than 12 years. Your doctor may direct you to take a low dose of aspirin to prevent blood clots. This effect reduces the risk of stroke and heart attack. If you have recently had surgery on clogged arteries (such as bypass surgery, carotid endarterectomy, coronary stent), your doctor may direct you to use aspirin in low doses as a blood thinner to prevent blood clots.

Product Characteristics

Color(s):
YELLOW (C48330)
Shape: ROUND (C48348)
Size(s):
5 MM
Imprint(s):
A1
Score: 1

NDC Code Structure

  • 10135 - Marlex Pharmaceuticals Inc

NDC 10135-689-62

Package Description: 120 TABLET in 1 BOTTLE

NDC Product Information

Aspirin 81 Mg Enteric Coated with NDC 10135-689 is a a human over the counter drug product labeled by Marlex Pharmaceuticals Inc. The generic name of Aspirin 81 Mg Enteric Coated is aspirin. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Marlex Pharmaceuticals Inc

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.

Aspirin 81 Mg Enteric Coated 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 81 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.

  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

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.
  • 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: Marlex Pharmaceuticals Inc
Labeler Code: 10135
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: 02-01-2020 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: 12-31-2021 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.

Aspirin 81 Mg Enteric Coated 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

Purpose

Drug FactActive ingredient (in each tablet) Purpose Aspirin 81mg (NSAID*)…………………………………………Pain Reliever*nonsteroidal anti-inflammatory drugAspirin 81 mg Tablets

Uses

  • Temporarily relieves minor aches and pains. For other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

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:HivesFacial SwellingShockAsthma (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 olderHave had stomach ulcers or bleeding problemsTake a blood thinning (anticoagulant) or steroid drugTake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)Have 3 or more alcoholic drinks every day while using this productTake more or for a longer time than directed

Do Not Use

If you are allergic to aspirin or any other pain reliever/fever reducer

Ask A Doctor Before Use If

  • Stomach bleeding warning applies to youYou have a history of stomach problems, such as heartburnYou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseYou are taking a diureticYou have asthmaYou have not been drinking fluidsYou have lost a lot of fluid due to vomiting or diarrhea

Ask A Doctor Or A Pharmacist Before Use If You Are

  • Taking a prescription drug for diabetes, gout, or arthritisUnder a doctor’s care for any serious conditionTaking any other drug

Stop Use And Ask A Doctor If

  • You experience any of the following signs of stomach bleedingFeel faintHave bloody or black stoolsVomit bloodHave stomach pain that does not get betterPain gets worse or lasts more than 10 daysRedness or swelling is present in the painful areaAny new symptoms appearRinging in the ears or a loss of hearing occurs

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 problem 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.

Directions:

  • Drink a full glass of water with each doseAdults 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 doctorChildren under 12 years: consult a doctor

Other Information:

  • Store at 25°C (77°F) excursions permitted between 15-30°C (59-86°F)Use by expiration date on package

Inactive Ingredients:

Microcrystalline Cellulose, Croscarmellose Sodium, Pregelatinized Starch, Stearic Acid, Colloidal Silicon Dioxide, Methacrylic Acid and Ethyl Acrylate Co-Polymer, Triethyl Citrate, Talc, Titanium Dioxide, D&C Yellow #10, FD&C Yellow #6

Questions?

Adverse Drug Event Call: (800) 222-1222Manufactured for & Distributed by:Marlex Pharmaceuticals, Inc.New Castle, DE 19720Rev: 12/19 HP

* Please review the disclaimer below.