NDC 0536-1232 Aspirin Regular Strength

Aspirin

NDC Product Code 0536-1232

NDC Code: 0536-1232

Proprietary Name: Aspirin Regular Strength 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):
ORANGE (C48331)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
44;227
Score: 1

NDC Code Structure

  • 0536 - Rugby Laboratories
    • 0536-1232 - Aspirin

NDC 0536-1232-01

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

NDC Product Information

Aspirin Regular Strength with NDC 0536-1232 is a a human over the counter drug product labeled by Rugby Laboratories. The generic name of Aspirin Regular Strength is aspirin. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Rugby Laboratories

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

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 Regular Strength 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.

  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • POLYDEXTROSE (UNII: VH2XOU12IE)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SHELLAC (UNII: 46N107B71O)
  • SODIUM ALGINATE (UNII: C269C4G2ZQ)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIACETIN (UNII: XHX3C3X673)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • WATER (UNII: 059QF0KO0R)
  • POWDERED CELLULOSE (UNII: SMD1X3XO9M)

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: Rugby Laboratories
Labeler Code: 0536
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: 06-01-2019 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.

Aspirin Regular Strength Product Label Images

Aspirin Regular Strength 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

Uses

For the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

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 swelling hives shockasthma (wheezing)Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]are age 60 or olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake more or for a longer time than directedhave 3 or more alcoholic drinks every day while using this product

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

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

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking a prescription drug fordiabetes arthritis  gout

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: vomit blood feel fainthave bloody or black stoolshave stomach pain that does not get betterringing in the ears or a loss of hearing occursnew symptoms occurpain gets worse or lasts more than 10 daysredness or swelling is presentThese 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 to 2 tablets every 4 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)see end flap for expiration date and lot number

Inactive Ingredients

Black iron oxide, cellulose, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

* Please review the disclaimer below.

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