NDC 0924-0104 Physicians Care Aspirin

Aspirin 325mg

NDC Product Code 0924-0104

NDC Code: 0924-0104

Proprietary Name: Physicians Care 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 325mg 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)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
TCL;011
Score: 1

NDC Code Structure

NDC 0924-0104-01

Package Description: 50 PACKET in 1 CARTON > 2 TABLET, COATED in 1 PACKET (0924-0104-00)

NDC 0924-0104-02

Package Description: 125 PACKET in 1 CARTON > 2 TABLET, COATED in 1 PACKET (0924-0104-00)

NDC 0924-0104-03

Package Description: 10 PACKET in 1 CARTON > 2 TABLET, COATED in 1 PACKET (0924-0104-00)

NDC 0924-0104-07

Package Description: 25 PACKET in 1 CARTON > 2 TABLET, COATED in 1 PACKET (0924-0104-00)

NDC Product Information

Physicians Care Aspirin with NDC 0924-0104 is a a human over the counter drug product labeled by Acme United Corporation. The generic name of Physicians Care Aspirin is aspirin 325mg. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Acme United Corporation

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.

Physicians Care 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)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • STARCH, CORN (UNII: O8232NY3SJ)

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: 02-24-2015 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.

Information for Patients

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.

Physicians Care Aspirin Product Label Images

Physicians Care 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

Drug Facts

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 with■ headache■ minor arthritis pain■ common cold■ menstrual cramps■ muscular aches■ backache■ toothacheTemporarily reduces fever.

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■ skin reddening■ facial swelling■ rash■ asthma (wheezing)■ blisters■ shockIf 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

Do Not Use

■ if you have ever had an allergic reaction to any other pain reliever/ fever reducer■ right before or after heart surgery■ if you are taking prescription drugs for gout, diabetes or arthritis

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

■ under a doctor's care for any serious condition■ taking any other drug

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 faint■ vomit blood■ have bloody or black stools■ have stomach pain that does not get better■ pain gets worse or lasts more than 10 days■ fever gets worse or lasts more than 3 days■ you have difficulty swallowing■ if ringing in the ears or loss of hearing occurs■ redness or swelling is present in the painful area■ any new symptoms appear

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.

Directions


do not take more than directed■
the 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 doseAdults and children: Take 1 or 2 tablets with water every 4 hours as needed. Do not
(12 years and older) 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.

Inactive Ingredients

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

Other Information

■ read all product information before using■ store at room temperature 59º-86ºF (15º-30ºC)■ avoid excessive heat and humidity■ tamper evident sealed packets■ do not use any opened or torn packets

Physicians Care Aspirin

Physicians Care®AspirinFever Reducer and Pain RelieverPull To OpenCoated TabletsTamper-Evident Packets of 2 TabletsPhysicians Care®Registered Trademark of Acme United Corporation50 Packets (2Tablets 325 Mg Each)

* Please review the disclaimer below.