NDC 68210-4093 Aspirin

Aspirin

NDC Product Code 68210-4093

NDC CODE: 68210-4093

Proprietary Name: 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.

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):
ORANGE (C48331)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
T
Score: 1

NDC Code Structure

  • 68210 - Spirit Pharmaceuticals Llc

NDC 68210-4093-1

Package Description: 300 TABLET, DELAYED RELEASE in 1 BOTTLE

NDC Product Information

Aspirin with NDC 68210-4093 is a a human over the counter drug product labeled by Spirit Pharmaceuticals Llc. The generic name of Aspirin is aspirin. The product's dosage form is tablet, delayed release and is administered via oral form.

Labeler Name: Spirit Pharmaceuticals Llc

Dosage Form: Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.

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 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)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

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: Spirit Pharmaceuticals Llc
Labeler Code: 68210
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 07-02-2020 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 Product Label Images

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

Purpose

Pain reliever

Indications & Usage

  • Temporary relieves minor aches and pains due to: headache minor arthritis paintoothachemenstrual paincolds or as recommended by a doctor

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:
  • Hivesshockfacial swellingasthma (wheezing)Stomach bleeding warning:  This product contains an NSAID, which may cause  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 producttake more or for a longer time than directed.

Do Not Use

If you have ever had an allergic reaction 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 asthma

Ask A Doctor Or Phamracist Before Use If You Are

Taking a prescription drug for diabetis, gout or arthritis

Stop Use And Ask A Doctor If

  • Allergic reaction occurs, Seek medical help right away.you experience any of the following signs of stomach bleeding:feel faint vomit bloodhave bloody or black stools have stomach pain that does not get betterpain gets worse or lasts more than 10 daysredness or swelling is presentany new symptom appearringing in the ears or a loss of hearing occursThese 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

  • Adults and children 12 years of age and over: take 1 to 2 tablets every 4 hours, while symptoms persist. Drink a full glass of water with each dose. do not take more than 12 tablets in 24 hours unless directed by a doctor children under 12 years of age: ask a doctor

Other Information

  • Store below 25
  • 0C (77
  • 0F)
  • Tampet Evident Feature: Do not use if printed inner-seal beneath cap is missing or broken

Inactive Ingredient

Corn starch, croscarmellose sodium,D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose,mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc,titanium dioxide, triethyl citrate

* Please review the disclaimer below.