NDC 0924-0204 First Aid Only Aspirin

Aspirin

NDC Product Code 0924-0204

NDC Code: 0924-0204

Proprietary Name: First Aid Only 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.

Product Characteristics

Color(s):
WHITE (C48325 - WHITE)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
TCL;011
Score: 1

NDC Code Structure

  • 0924 - Acme United Corporation

NDC 0924-0204-01

Package Description: 20 PACKET in 1 BOX, UNIT-DOSE > 2 TABLET, FILM COATED in 1 PACKET

NDC Product Information

First Aid Only Aspirin with NDC 0924-0204 is a a human over the counter drug product labeled by Acme United Corporation. The generic name of First Aid Only Aspirin is aspirin. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Acme United Corporation

Dosage Form: Tablet, 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.

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.

First Aid Only 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.

  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: Acme United Corporation
Labeler Code: 0924
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: 12-30-2008 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.

First Aid Only Aspirin Product Label Images

First Aid Only 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

Other

Drug Facts

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)If an allergic reaction occurs, stop use and seek medical help right away.

  • 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 alcohol drinks every day while
  • Using this product
  • Take more or for a longer time than directed

Active Ingredient (In Each Tablet)

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

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains associated withheadache
  • Minor arthritis
  • Common cold
  • Menstrual cramps
  • Muscular aches
  • Backache
  • Toothache
  • Temporarily reduces fever.

Do Not Use

  • If you are allergic to aspirinor 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 diuretic you have asthma

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking prescription drugs for gout, diabetes or arthritis

When Using This Product

  • Take with food or milk if stomach upset occurs

Stop Use And Ask A Doctor If

  • You experience any of the following signs of stomach bleeding:feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betterpain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysif ringing in the ears or loss of hearing occursredness or swelling is present in the painful areaany new symptoms appearan allergic reaction occurs. Seek medical help right away.

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.

Directions

  • Do not take more than directedthe smallest effective dose should be used do not take longer than 10 days, unless
  • Directed by a doctor (see
  • Warnings)
  • Drink a full glass of water with each dose

Adults And Children: (12 Years And Older)

Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor.

Children Under 12 Years:

Do not give to children under 12 years of age.

Other Information

  • Read all product information before usingstore at room temperature 59º-86ºF (15º-30ºC)avoid excessive heat and humiditytamper evident sealed packetsdo not use any opened or torn packets

Inactive Ingredients

Corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

First Aid Only Aspirin Label

First Aid Only Label

* Please review the disclaimer below.